Label: ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-305-02 - Packager: CVS PHARMACY,INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 19, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purposes
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Uses
temporarily relieves these symptoms due to cold and flu:
- sneezing
- itching of the nose, throat or watery eyes due to hay fever
- cough
- nasal congestion
- sinus congestion and pressure
- sore throat
- head ache
- minor aches and pains
helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever
- Warnings
- Liver warning
- Allergy alert
- Sore throat warning
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Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age. - Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs - If pregnant or breast-feeding
- Keep out of the reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredients
- Purposes
-
Uses
temporarily relieves these symptoms due to cold and flu:
- sneezing
- itching of the nose, throat or watery eyes due to hay fever
- cough
- nasal congestion
- sinus congestion and pressure
- sore throat
- headache
- minor aches and pains
- runny nose
helps clear nasal passages and shrinks swollen membranes
temporarily reduces fever - Warnings
- Liver warning
- Allergy alert
- Sore throat warning
- Warnings
-
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age. -
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes• glaucoma
• cough with excess phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough occurs with smoking, asthma, or emphysema - Ask a doctor or pharmacist before use if you are
- When using this product
-
Stop use and ask a doctor if
• pain, cough, or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs - If pregnant or breast-feeding
- Keep out of the reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL
acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-305 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green (Nighttime) , blue (Daytime) Score no score Shape OVAL Size 20mm Flavor Imprint Code 314;116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-305-02 20 in 1 PACKAGE, COMBINATION 07/07/2017 1 8 in 1 BLISTER PACK 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/07/2017 Labeler - CVS PHARMACY,INC (062312574)