Label: CAREONE ACID REDUCER- lansoprazole capsule, delayed release
- NDC Code(s): 41520-816-01, 41520-816-02, 41520-816-03
- Packager: American Sales Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each capsule)
- Purpose
- Use
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Warnings
Allergy alert: Do not use if you are allergic to lansoprazole
Do not use
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- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
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- liver disease
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- heartburn with lightheadedness, sweating or dizziness
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- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
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- frequent chest pain
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Ask a doctor or pharmacist before use if you are
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- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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Directions
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- adults 18 years of age and older
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- this product is to be used once a day (every 24 hours), every day for 14 days
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- it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
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- swallow 1 capsule with a glass of water before eating in the morning
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- take every day for 14 days
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- do not take more than 1 capsule a day
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- swallow whole. Do not crush or chew capsules.
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- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
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- you may repeat a 14-day course every 4 months
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- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
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- children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
- Inactive ingredients
- Questions or comments?
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Consumer Information
Treats Frequent Heartburn
Lansoprazole
Delayed-Release Capsules 15 mg / Acid Reducer
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- May take 1 to 4 days for full effect
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- Sodium Free
Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg.
Save for future reference.
How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn
Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.
What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg
Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.
Who Should Take Lansoprazole Delayed-Release Capsules 15 mg
Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.
Who Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg
People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.
How to Take Lansoprazole Delayed-Release Capsules 15 mg
14-DAY Course of Treatment
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- Swallow 1 capsule with a glass of water before eating in the morning.
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- Take every day for 14 days.
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- Do not take more than 1 capsule a day.
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- Swallow whole. Do not crush or chew capsules.
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- Do not use for more than 14 days unless directed by your doctor.
When to Take Lansoprazole Delayed-Release Capsules 15 mg Again
You may repeat a 14-day course of therapy every 4 months.
When to Talk to Your Doctor
Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.
Warnings and When to Ask Your Doctor
Allergy alert: Do not use if you are allergic to lansoprazole
Do not use
- •
- if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have
- •
- liver disease
- •
- had heartburn over 3 months. This may be a sign of a more serious condition.
- •
- heartburn with lightheadedness, sweating or dizziness
- •
- chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
- •
- frequent chest pain
- •
- frequent wheezing, particularly with heartburn
- •
- unexplained weight loss
- •
- nausea or vomiting
- •
- stomach pain
Ask a doctor or pharmacist before use if you are
- •
- taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if
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- your heartburn continues or worsens
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- you need to take this product for more than 14 days
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- you need to take more than 1 course of treatment every 4 months
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- you get diarrhea
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- you develop a rash or joint pain
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Tips for Managing Heartburn
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- Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
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- Eat slowly and do not eat big meals.
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- Do not eat late at night or just before bedtime.
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- Do not lie flat or bend over soon after eating.
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- Raise the head of your bed.
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- Wear loose-fitting clothing around your stomach.
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- If you are overweight, lose weight.
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- If you smoke, quit smoking.
Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn
In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.
How Lansoprazole Delayed-Release Capsules 15 mg is Sold
Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.
For Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg
Call 1-800-719-9260
Distributed By
Perrigo®
Allegan, MI 49010
: 3T300 00 J6
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Package/Label Principal Display Panel
BONUS SIZE
100% MORE
Compare to the active ingredient in Prevacid® 24 HR
ACID REDUCER
Lansoprazole Delayed-Release Capsules 15mg
Acid Reducer
May take 1 to 4 days for full effect
Sodium Free
24hr
Actual Size
Treats Frequent Heartburn
Gluten Free
14 + 14 = 28
28 CAPSULES
OUR PHARMACISTS RECOMMEND
Two 14-day courses of treatment
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INGREDIENTS AND APPEARANCE
CAREONE ACID REDUCER
lansoprazole capsule, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-816 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE 15 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MANNITOL (UNII: 3OWL53L36A) MEGLUMINE (UNII: 6HG8UB2MUY) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color PINK, GREEN Score no score Shape CAPSULE Size 16mm Flavor Imprint Code L3T3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-816-01 1 in 1 CARTON 10/14/2016 1 14 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:41520-816-02 2 in 1 CARTON 10/14/2016 2 14 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:41520-816-03 3 in 1 CARTON 10/14/2016 3 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202319 10/14/2016 Labeler - American Sales Company (809183973)
