ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled 
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.

----------

Drug Facts

Active ingredients (in each liquid-filled capsule)

Acetaminophen, USP 325 mg

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
headache
sore throat
cough
minor aches and pains
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily reduces fever

Warnings

Liver warning

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

more than 8 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

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
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
glaucoma
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, 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
taking sedatives or tranquilizers

When using this product

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
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 8 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 6 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

D&C yellow no. 10, FD&C blue no. 1, 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

PRINCIPAL DISPLAY PANEL

ADULT

Robitussin®

 
MAXIMUM
STRENGTH
 
SEVERE
Multi-Symptom
7 in 1 Relief

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

CF
NIGHTTIME
MAX

1.
Cough, Sore Throat
2.
Body Aches, Fever
3.
Runny Nose, Sneezing
4.
Itchy Throat

For Ages 12 & Over

10
LIQUID-FILLED
CAPSULES

Robitussin MS S Multi Sym 10 Caps Blister Pack Carton
ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8744
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 HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize16mm
FlavorImprint Code R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-8744-105 in 1 CARTON07/01/2018
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2020
Document Id: c1631d7e-c920-4f6b-b6fa-e63e081f997c
Set id: e7cf7c5d-5c9a-4201-9e30-1cd616071855
Version: 3
Effective Time: 20201103
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC