ONLY FOR ALLERGY- diphenhydramine hcl tablet 
O4 Global Trading Usa, 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.

----------

Only For ALLERGY

Drug Facts

Active ingredient (in each caplet)

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
   • 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
• 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 drinks
• 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 overdose, get medical help or contact a Poison Control Center right away.

Directions:

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

 adults and children 12 years and over• take 1 to 2 caplets 
 children 6 to under 12 years• take 1 caplet
 children under 6 years• do not use

Other Information:

• store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F).
• avoid excessive heat and light.
• store in dry place.

Inactive Ingredients:

croscarmellose sodium, dicalcium phosphate, D&C red No.27 aluminium lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-833-665-9444.
(Mon-Fri 9am - 5pm)

ANTIHISTAMINE NIGHTTIME SLEEP-AID

TAMPER EVIDENT Do not use if imprinted safety seal under cap is broken or missing

Distributed By: O4 GLOBAL TRADING USA, LLC.
12222 Merit Drive, Suite 1900
Dallas, TX 75251-3209

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc.
East Brunswick, NJ 08816.

Packaging

IMAGE

ONLY FOR ALLERGY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-148
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVAL (CAPLET) Size11mm
FlavorImprint Code DP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73006-148-951 in 1 CARTON11/15/2020
125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/15/2020
Labeler - O4 Global Trading Usa, Llc (081226861)

Revised: 11/2020
Document Id: 93e01654-953a-4541-b44f-fb5daa7a9ecb
Set id: 5d4b2c79-9580-44a4-9f9f-f9a006d47143
Version: 1
Effective Time: 20201118
 
O4 Global Trading Usa, Llc