ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet 
Pioneer Life Sciences, 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.

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Active Ingredient

Diphenhydramine Hcl 25mg

Purpose

Antihistamine

Uses:

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
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 Doctor:

Ask a doctor before use if you have - glaucoma - troble urinating due to an enlarged prostate gland - a breathing problem such as emphysema or chronic bronchitis

ASK DOCTOR/PHARMACIST:

Ask a doctor or pharmacist before use if you aretaking 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

PREGNANCY

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DIRECTIONS

if needed, repeat dose every 4 to 6 hours
do not take more than 6 times in 24 hours
adults and children 12 years of age or older - 1 to 2 caplets
children 6 to under 12 years - 1 caplet
children under 6 years of age - do not use.

OTHER INFORMATION

each tablets contains: calcium 24 mg - store between 20-25°C (68-77°F). Avoid high humidity. Protect from moisture and light

INACTIVE INGREDIENTS

Dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

QUESTIONS OR COMMENTS?

Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

PRINCIPAL DISPLAY PANEL

Label

ALLERGY RELIEF 
diphenhydramine hcl 25 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-021
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
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-021-60600 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/29/2020
Labeler - Pioneer Life Sciences, LLC (014092742)

Revised: 7/2020
Document Id: ab45294c-3a57-a403-e053-2995a90a0fdd
Set id: ab45ae97-7951-4058-e053-2995a90a7b2e
Version: 1
Effective Time: 20200725
 
Pioneer Life Sciences, LLC