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

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Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever/Fever reducer

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

Additional information

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

Distributed by: Haleon, Warren, NJ 07059

For most recent product information, visit www.robitussin.com

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

Pat. Info www.productpats.com

Made in Canada

PRINCIPAL DISPLAY PANEL

ADULT
Robitussin

Honey

Nighttime

SEVERE
Cough, Flu +
Sore Throat

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

MAXIMUM STRENGTH

Controls Cough
Relieves Runny Nose & Sneezing
Relieves Fever & Body Aches

Taste the Real Honey
with Vanilla

CF
NIGHTTIME
MAX

For Ages 12+

8 FL OZ (237 mL)

Robitussin Honey SC F+ST NT 8 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)

Revised: 4/2024
Document Id: e1aff09c-8c75-45af-b83c-71be0cb7309b
Set id: 7decc168-e847-4bbe-910b-26081469406f
Version: 7
Effective Time: 20240426
 
Haleon US Holdings LLC