ONLY FOR SLEEP- diphenhydramine hcl tablet

Only For by

Drug Labeling and Warnings

Only For by is a Otc medication manufactured, distributed, or labeled by O4 Global Trading Usa, Llc . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient (in each caplet)

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid

Uses:

for relief of occasional sleeplessness

Warnings:

Do not use:

• in children under 12 years of age
• 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 before use if you
are taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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:

• take with a full glass of water
• do not take more than directed
  • adults and children 12 years of age and over: 2 caplets at bedtime if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other Information:

• Store at room temperature between 20-25°C (68-77°F)
• Avoid high humidity  Protect from light

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ONLY FOR  SLEEP
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73006-111
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
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
Color	blue	Score	no score
Shape	OVAL (CAPLET)	Size	12mm
Flavor		Imprint Code	S1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-111-41	1 in 1 CARTON	03/29/2019
1		4 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	part338	03/29/2019

Labeler - O4 Global Trading Usa, Llc (081226861)