ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT- acetaminophen, dextromethorphan hbr solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients (in each 20 ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Uses

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

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.

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 21 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, zinc gluconate

Questions or comments?

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

Distributed by: Pfizer, Madison, NJ 07940 USA

©2020 Pfizer Inc.

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

For US Patent or Application status use www.productpats.com

Should be 18 or older to purchase

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

PRINCIPAL DISPLAY PANEL

NDC 0031 8771 18

Robitussin®

Honey

ADULT
NEW!

SEVERE
Cough, Flu +
Sore Throat

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

NON-DROWSY

MAXIMUM STRENGTH

1.
Controls Cough
2.
Soothes Sore Throat Pain
3.
Relieves Fever & Body Aches

Taste the Real Honey
with Elderberry

CF
MAX

For Ages 12+

8 FL OZ (237 ml)

Robitussin Honey CF Max 8 fl ozs
ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT 
acetaminophen, dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8771
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 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)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8771-121 in 1 CARTON06/15/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-8771-181 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 finalpart34106/15/2020
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2023
Document Id: d511de1c-8caa-49de-8742-a6922d31099c
Set id: 77be57fb-0ae5-4fad-97f3-b6a4b57383a9
Version: 5
Effective Time: 20230125
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC