Sleepaid Softgels diphenhydramine Hcl 50 Mg

Sleepaid Softgels diphenhydramine Hcl 50 Mg
SPL v2
SPL
SPL Set ID c1dab616-c3ff-4d0a-be13-e8dc6b1a26cc
Route
ORAL
Published
Effective Date 2024-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Gelatin Sorbitol Sorbitan Glycerin Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-25

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid


Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Uses

for relief of occasional sleeplessness

Section 42229-5

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

Distributed by: Gencare Consumer Products, LLC

40E Cotters Ln, Suite A, East Brunswick, NJ 08816

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

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.

Section 50568-5

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

Section 53414-9

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

Directions:

Adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.

Do Not Use:
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Other Information:

store between 15-30°C (59-86°F). Avoid high humidity. Protect from light.

Inactive Ingredients:

Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

Questions Or Comments?

Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

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.
Ndc 72090 023 02 (96 Sofgels T in Hdpe Bottle)


Structured Label Content

Uses

for relief of occasional sleeplessness

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

Distributed by: Gencare Consumer Products, LLC

40E Cotters Ln, Suite A, East Brunswick, NJ 08816

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Purpose

Nighttime sleep-aid

Directions:

Adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.

Do Not Use: (Do not use:)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
Other Information:

store between 15-30°C (59-86°F). Avoid high humidity. Protect from light.

Inactive Ingredients:

Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

Questions Or Comments?

Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

Active Ingredient (in Each Softgel) (Active Ingredient (In Each Softgel))

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (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.
Ndc 72090 023 02 (96 Sofgels T in Hdpe Bottle) (NDC 72090-023-02 (96 Sofgels t in HDPE Bottle))


Advanced Ingredient Data


Raw Label Data

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