ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT- acetaminophen, dextromethorphan hbr solution

Robitussin Honey Severe Cough, Flu Plus Sore Throat by

Drug Labeling and Warnings

Robitussin Honey Severe Cough, Flu Plus Sore Throat 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]

Active ingredients (in each 20 mL)

Acetaminophen, USP 650 mg

Dextromethorphan HBr 20 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat pain
  • headache
• 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

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product do not use more than directed.

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 21 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, zinc gluconate

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.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Distributed by: Haleon, Warren, NJ 07059

©2024 Haleon group of companies or its licensor.

Trademarks are owned by or licensed to the Haleon group of companies.

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

Pat. Info www.productpats.com

Made in Canada

PRINCIPAL DISPLAY PANEL

Robitussin

Honey

ADULT

SEVERE
Cough, Flu +
Sore Throat

ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)

NON-DROWSY

MAXIMUM STRENGTH

• ✓ Controls Cough
• ✓ Soothes Sore Throat Pain
• ✓ Relieves Fever & Body Aches

Taste the Real Honey
with Elderberry

CF
MAX

For Ages 12+

8 FL OZ (237 mL)

62000000207916 – Front Carton

INGREDIENTS AND APPEARANCE

ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT 
acetaminophen, dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-8771
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 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)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-8771-12	1 in 1 CARTON	06/15/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-8771-18	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)