ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME- acetaminophen and diphenhydramine hydrochloride solution 
Haleon US Holdings LLC

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Robitussin ®Honey Severe Cough, Flu Plus Sore Throat Nighttime

Drug Facts

Active ingredients (in each 20 ml)Purposes

Acetaminophen, USP 650 mg

Pain reliever/Fever reducer

Diphenhydramine HCl, USP 25 mg

Antihistamine/Cough suppressant

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat pain
    • headache
    • runny nose, sneezing, itchy watery eyes
    • itching of the nose and throat
  • temporarily relieves your cough to help you sleep
  • temporarily reduces fever

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 product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, emphysema or chronic bronchitis
  • if you have glaucoma or difficulty in urination due to enlargement of prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer

When using this product

  • do not use more than directed
  • 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

  • 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
Agedose

adults and children 12 years and over

20 ml every 4 hours

children under 12 years

do not use

Other information

  • each 20 ml contains: sodium 22 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural & artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum

Questions or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Distributed by: Pfizer, Madison, NJ 07940 US

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

ADULT
NEW!

Robitussin ®

Honey

Nighttime

SEVERE
Cough, Flu +
Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)

MAXIMUM STRENGTH

  1. Controls Cough
  2. Relieves Runny Nose & Sneezing
  3. Relieves Fever & Body Aches

Taste the Real Honey
with Vanilla

TRUE
SOURCE
CERTIFIED
HONEY✔™

CF
NIGHTTIME
MAX

For Ages 12+

4 FL OZ (118 ml)

Robitussin Honey SC F+ST NT 4 oz
ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME 
acetaminophen and diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8770
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)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
HONEY (UNII: Y9H1V576FH)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8770-121 in 1 CARTON06/15/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8770-181 in 1 CARTON06/15/2020
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/15/2020
Labeler - Haleon US Holdings LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
WestRock Converting, LLC080204731label(0031-8770) , pack(0031-8770)

Revised: 3/2024
 
Haleon US Holdings LLC