ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ROBITUSSIN® PEAK COLD DAYTIME COLD + FLU

Drug Facts

Active ingredients (in each liquid-filled capsule)Purposes

Acetaminophen, USP 325 mg

Pain reliever/Fever reducer

Dextromethorphan HBr, USP 10 mg

Cough suppressant

Phenylephrine HCl, USP 5 mg

Nasal decongestant

Uses

temporarily relieves these symptoms occurring with a cold or flu:
headache
nasal congestion
sore throat
cough
minor aches and pains
temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 12 capsules 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

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
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a 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 oral nasal decongestant or stimulant
taking any other pain reliever/fever reducer

When using this product do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless
pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
new symptoms occur

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 12 capsules in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
this adult product is not intended for use in children under 12 years of age
agedose

adults and children 12 years and over

2 capsules every 4 hours

children under 12 years

do not use

Other information

store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

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

Distributed by: Pfizer, Madison, NJ 07940 USA

Made in Canada

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

PRINCIPAL DISPLAY PANEL - 20 Capsule Carton

ADULT

Robitussin®

PEAK COLD

DAYTIME

Cold + Flu

ACETAMINOPHEN (Pain Reliever / Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Body Ache
Fever
Sore Throat
Nasal Congestion

Non-Drowsy

For Ages 12 & Over

20
LIQUID-FILLED
CAPSULES

Principal Display Panel - 20 Capsule Carton
ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8721
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K12 (UNII: 333AG72FWJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorORANGE (clear orange) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8721-2020 in 1 CARTON04/15/201206/30/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0031-8721-0230 in 1 CARTON04/15/201206/30/2017
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/15/201206/30/2017
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 12/2021
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC