Label: ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME- acetaminophen, diphenhydramine hcl liquid
- NDC Code(s): 0031-0101-04
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
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INDICATIONS & USAGE
Uses
- temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
- cough due to minor throat and bronchial irritation
- headache
- sore throat
- minor aches and pains
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves your cough to help you rest
- temporarily reduces fever
- temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:
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WARNINGS
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in any 24-hour period, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using 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
- to sedate a child or to make a child sleepy
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- liver disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking any other pain reliever/fever reducer
- taking sedatives or tranquilizers
When using this product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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DOSAGE & ADMINISTRATION
Directions
- do not take more than 6 doses in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- this adult product is not intended for use in children under 12 years of age
age dose adults and children
12 years and over
20 mL every 4 hours
children under 12 years
do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
-
Additional information
Do Not Use if breakable ring on bottle cap is separated or missing.
ADULT
Robitussin
MAXIMUM STRENGTH
SEVERE MULTI-SYMPTOM
Cough Cold + Flu CFNIGHTTIME MAX
Distributed by: Haleon, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by Haleon.
Pat. Info www.productpats.com
©2023 Haleon or licensor. Made in Canada
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PRINCIPAL DISPLAY PANEL
ADULT NEW FORMULA HALEON
Robitussin
MAXIMUM STRENGTH
SEVERE
MULTI-SYMPTOM
Cough Cold + FluNighttime
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)Relieves Cough to Help You Rest
✓Cough, Sore Throat
✓Head & Body Aches, Fever
✓Runny Nose, SneezingFAST, POWERFUL
multi-symptom reliefCF
NIGHTTIME
MAXFor Ages 12 & Over
4 FL OZ (237 mL)207723 Front Carton
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INGREDIENTS AND APPEARANCE
ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME
acetaminophen, diphenhydramine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-0101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color red Score Shape Size Flavor CHERRY, RASPBERRY, Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-0101-04 1 in 1 CARTON 02/15/2024 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/15/2024 Labeler - Haleon US Holdings LLC (079944263)