COMPLETE ALLERGY SOFTGEL- diphenhydramine hcl capsule, liquid filled
Chain Drug Consortium

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 ingredient

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use with any other products containing diphenhydramine, including one applied topically

Ask a doctor if you have

a breathing problem such as emphysema or chronic bronchitis, glaucoma or 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 be careful 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 accidental overdose, contact a doctor or Poison Control Center immediately

Directions

take every 4 to 6 hours do not take more than 6 doses in 24 hours
Adults and children 12 years of age and older: 25 mg to 50 mg (1 to 2 softgels)
Children 6 to under 12 years of age: 25 mg (1 softgel)
Children under 6 years of age: Do not use

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol.

Package/Label Principal Display Panel

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COMPLETE ALLERGY SOFTGEL
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-150
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-150-00	24 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/29/2014	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/29/2014	10/01/2018

Labeler - Chain Drug Consortium (101668460)

Registrant - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	label(68016-150) , manufacture(68016-150) , pack(68016-150) , relabel(68016-150) , repack(68016-150)

Revised: 10/2018

Document Id: 78d736ac-7012-9416-e053-2991aa0a194d

Set id: cc239c9b-510b-4425-8224-1447a449eab9

Version: 2

Effective Time: 20181022

Chain Drug Consortium