ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME- acetaminophen, diphenhydramine hcl liquid 
Haleon US Holdings LLC

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Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Uses

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

Stop use and ask a doctor if

  • pain or cough 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.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

agedose

adults and children

12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

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

PRINCIPAL DISPLAY PANEL

ADULT NEW FORMULA HALEON

Robitussin

MAXIMUM STRENGTH

SEVERE
MULTI-SYMPTOM
Cough Cold + Flu

Nighttime

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, Sneezing

FAST, POWERFUL
multi-symptom relief

CF
NIGHTTIME
MAX

For Ages 12 & Over
4 FL OZ (237 mL)

207723 Front Carton

Robitussin Severe Multi-Symptom CC+F NT 4 fl oz (118 mL)
ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME 
acetaminophen, diphenhydramine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-0101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorredScore    
ShapeSize
FlavorCHERRY, RASPBERRY, Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-0101-041 in 1 CARTON02/15/2024
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/15/2024
Labeler - Haleon US Holdings LLC (079944263)

Revised: 1/2024
Document Id: 0f9df094-b106-76fc-e063-6294a90a6a18
Set id: 721bfee2-0d3d-4d8b-beee-1ea83064d1c8
Version: 1
Effective Time: 20240123
 
Haleon US Holdings LLC