Only For-

Only For-
SPL v1
SPL
SPL Set ID c4ac8d9f-7bde-4b49-86b0-19a007a934df
Route
ORAL
Published
Effective Date 2019-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Blue No. 4 Dibasic Calcium Phosphate Dihydrate Hypromellose 2910 (5 Mpa.s) Isopropyl Alcohol Magnesium Palmitostearate Microcrystalline Cellulose 101 Polyethylene Glycol 400 Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-29

Description

Diphenhydramine HCL 25mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCL 25mg

Uses:

for relief of occasional sleeplessness

Section 42229-5

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

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.

Drug Facts

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.

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.

Active Ingredient (in Each Caplet)

Diphenhydramine HCL 25mg


Structured Label Content

Uses:

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

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

Purpose

Nighttime sleep-aid

Packaging

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.

Drug Facts (DRUG FACTS)

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.

Keep Out of Reach of Children (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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCL 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)