ALLERGY RELIEF DYE-FREE SOFTGEL- diphenhydramine hydrochloride capsule, liquid filled

Allergy Relief Dye-Free Softgel by

Drug Labeling and Warnings

Allergy Relief Dye-Free Softgel by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel)

Diphenhydramine HCl 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   a breathing problem such as emphysema or chronic bronchitis  glaucoma   difficulty in urination due to enlargement to the 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.

Overdose warning: 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 children even if you do not notice any signs or symptoms.

Directions

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

• adults and children 12 years and older: 1 to 2 softgels
• children 6 to under 12 years: 1 softgel
• children 6 under years: do not use

Other information

  store at 25°C (77°F) in a dry place
  protect from light, heat and moisture

Inactive ingredients

gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-888-577-8033 Monday-Friday 9am-4:30pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredients in Benadryl® Dye-Free Allergy LIQUID-GELS®*

RELIEF OF:
SNEEZING 
RUNNY NOSE 
ITCHY, WATERY EYES 
ITCHY THROAT

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson&Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy LIQUID GELS®

Product of UAE
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Packaging

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF DYE-FREE SOFTGEL 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-998
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	white (Clear Transparent)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	780
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-998-22	2 in 1 CARTON	07/20/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/20/2021

Labeler - CVS PHARMACY, INC (062312574)