Label: NIGHTTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 76162-732-24
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 8, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each softgel)
- Purposes
- Uses
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Warnings
Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this productAllergy alert:
Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash n hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or general allergic 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 to sedate children.
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 have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of ageAsk a doctor before use if you have
• liver disease n heart disease n high blood pressure
• thyroid disease n diabetes
• cough with excessive phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysemaAsk a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizersWhen using this product
• do not exceed recommended dosage
• may cause marked drowsiness n avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• n excitability may occur, especially in childrenStop 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 headache that lasts. These could be signs of a serious condition.
• nervousness, dizziness, or sleeplessness occurs
If pregnant or breast-feeding, ask a health professional before use. - Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Carton
TopCare health
NDC 36800-732-24
COMPARE TO ALKA-SELTZER® PLUS®
MAXIMUM STRENGTH NIGHTTIME COLD & FLU
POWERMAXTM GELS ACTIVE INGREDIENTS
NIGHTTIME
Cold & Flu Max Softgels
MAXIMUM STRENGTHPAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
NASAL DECONGESTANT - PHENYLEPHRINE HCl
RELIEVES:
• Nasal Congestion
• Cough
• Headache & Body Ache
• Sore Throat
• Runny Nose•Smaller Capsule •Same Strength
24SOFTGELS**
**Liquid-Filled CapsulesCarton
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-732 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 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) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL ((oblong)) Size 16mm Flavor Imprint Code 106 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-732-24 2 in 1 CARTON 04/20/2022 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 Drug M012 04/20/2022 Labeler - TOPCO ASSOCIATES LLC (006935977)