ROBITUSSIN DIRECT RUNNY NOSE- diphenhydramine tablet, coated 
Haleon US Holdings LLC

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Drug Facts

Active ingredient (in each tablet)

Diphenhydramine HCI 25 mg

Purpose

Antihistamine

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
runny nose
•
itchy, watery eyes
•
sneezing
 
itching of the nose or throat
•
temporarily relieves these symptoms due to the common cold:
•
runny nose
•
sneezing

Warnings

Do not use

•
to make a child sleepy
•
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

•
glaucoma
•
a breathing problem such as emphysema or chronic bronchitis
•
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

•
marked drowsiness may occur
•
avoid alcoholic beverages
•
alcohol, sedatives, and tranquilizers may increase drowsiness
•
use caution when driving a motor vehicle or operating machinery
•
excitability may occur, especially in children

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.

Directions

•
do not take more than directed
•
take every 4 to 6 hours, or as directed by a doctor
•
do not take more than 6 times in 24 hours

adults and children 12 years and over

1 to 2 tablets

Children 6 to under 12 years

1 tablet

children under 6 years

do not use

Other information

•
each tablet contains: calcium 30 mg
•
store at 20-25°C (68-77°F)

Inactive ingredients

D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch,

silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional Information

Do not use if safety seal under cap printed with “Sealed for Your Protection” is broken or missing.

Lift Here for More Drug Facts

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

visit www.robitussin.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor.

Made in China

PRINCIPAL DISPLAY PANEL

NEW

Robitussin

Runny Nose
Diphenhydramine HCl

(Antihistamine)

direct

Actual size

18
Tablets
L-0630-329-44-UPC_ORG Front Label

Robitussin Direct Runny Nose 18 caplets
ROBITUSSIN DIRECT RUNNY NOSE 
diphenhydramine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-9304
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-9304-0118 in 1 BOTTLE; Type 0: Not a Combination Product07/15/202205/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/15/202205/15/2024
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: f466be59-73f9-4d0a-9b6e-866850bda6ad
Set id: 7a049de2-8f24-4cb3-8b30-331db00a455e
Version: 4
Effective Time: 20240412
 
Haleon US Holdings LLC