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

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime by

Drug Labeling and Warnings

Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

INDICATIONS & USAGE

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

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.

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

Other information

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

INACTIVE INGREDIENT

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

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)

INGREDIENTS AND APPEARANCE

ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT NIGHTTIME 
acetaminophen and diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8770
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)
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
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8770-12	1 in 1 CARTON	06/15/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-8770-18	1 in 1 CARTON	06/15/2020
2		237 mL in 1 BOTTLE; 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	06/15/2020

Labeler - Haleon US Holdings LLC (079944263)