Label: DAYTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 51013-183-14
- Packager: PuraCap Pharmaceutical LLC
- 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 December 20, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (in each softgel)
- Purposes
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with excessive phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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 headache that lasts. These could be signs of a serious condition.
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Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
2 softgels with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-183 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange (clear) Score no score Shape capsule (oblong) Size 20mm Flavor Imprint Code PC9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-183-14 2 in 1 CARTON 07/15/2016 1 8 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 07/15/2016 Labeler - PuraCap Pharmaceutical LLC (962106329) Establishment Name Address ID/FEI Business Operations Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(51013-183) , analysis(51013-183)
