ONLY FOR SLEEP- 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.

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Only For- SLEEP

DRUG FACTS

Active ingredient (in each caplet)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Uses:

for relief of occasional sleeplessness

Warnings:

Do not use:

Ask a doctor before use if you have:

Ask a doctor before use if you
are taking sedatives or tranquilizers

When using this product

Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Keep out of reach of children

Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions:

Other Information:

Inactive Ingredients:

Croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide.

Questions Or Comments ?

1-833-665-9444.

NDC: 73006-111-41

NIGHTTIME SLEEP-AID

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

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

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

Tear along perforation push product through foil

Packaging

OnlyFor

ONLY FOR  SLEEP
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-111
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)  
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (CAPLET) Size12mm
FlavorImprint Code S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73006-111-411 in 1 CARTON03/29/2019
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33803/29/2019
Labeler - O4 Global Trading Usa, Llc (081226861)

Revised: 4/2019
Document Id: 9db406a0-2264-4315-a554-37b5e9387305
Set id: c4ac8d9f-7bde-4b49-86b0-19a007a934df
Version: 1
Effective Time: 20190425
 
O4 Global Trading Usa, Llc