Label: DAY-TIME COLD/FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 76281-506-28
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients(in each 15 mL, 1 tablespoon)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult/child takes: ■ more than
4 doses in 24 hours, which is the maximum daily amount for this product ■ with other drugs containing
acetaminophen ■ 3 or more alcoholic drinks everyday while usina this product.
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.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly -
Do not use
■ 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product. ■ for more than 10 days for pain unless directed by a doctor. ■ for more than 3 days for fever unless directed by a doctor. ■ with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
-
Stop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ new symptoms occur
■ fever gets worse or lasts more than 3 days
■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
■ redness or swelling is present
■ cough comes back or occurs with rash or headache that lasts.
These couldbe signs of a serious condition. - If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
- Overdose Warning:
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Directions
■ take only as recommended (see overdose warning)
■ use dosage cup or tablespoon (TBSP)
■ do not exceed 4 doses per 24 hoursage dose
adults & children 12 years and over 30 mL (2 TBSP) every 4 hours
children 6 to under 12 years 15 mL (1 TBSP) every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not useWhen using Day Time and Night Time products, carefully read each label to
ensure correct dosing. - Other information
- Inactive Ingredients
- Questions?
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Product Package Label - Day Time Cold & Flu Relief
AP SAFE
*COMPARE TO
the active ingredients in
VICKS® DAYQUIL®Day Time
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCI – Nasal DecongestantCold & Flu Relief
Multi-Symptom Relief
12 FL OZ (354 mL)
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® DayQuil®.Manufactured by: AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110LOT: EXP:
12 OZ
res
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INGREDIENTS AND APPEARANCE
DAY-TIME COLD/FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-506 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) Acetaminophen 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-506-28 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/01/2018 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-506)