Drugplain

Somnapure Clinical Strength 50 mg/1

Diphenhydramine Hydrochloride · TABLET, COATED · Force Factor Brands LLC

No Recall History
Plain English

Somnapure Clinical Strength is a tablet, coated containing diphenhydramine hydrochloride at 50 mg/1, taken oral. Manufactured by Force Factor Brands LLC.

Key Facts

Brand Name
Somnapure Clinical Strength
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
69721-005
Manufacturer
Force Factor Brands LLC
Strength
50 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
03/20/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue3,478 reports
off label use3,146 reports
pain3,114 reports
headache3,112 reports
drug ineffective2,811 reports
infusion related reaction2,770 reports
arthralgia2,704 reports
nausea2,684 reports
nasopharyngitis2,384 reports
pneumonia2,297 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps to reduce difficulty in falling asleep

Dosage & Administration

Directions adults and children 12 years and over: take 1 caplet at bedtime if needed or as directed by a doctor Children under 12 years: do not use.

Warnings

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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product , avoid alcoholic beverages. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breastfeeding, 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 (1-800-222-1222) right away.

Frequently Asked Questions

What is Somnapure Clinical Strength used for?

Somnapure Clinical Strength contains Diphenhydramine Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Somnapure Clinical Strength a controlled substance?

Somnapure Clinical Strength is not classified as a controlled substance by the DEA.

What is the generic name for Somnapure Clinical Strength?

The generic name for Somnapure Clinical Strength is Diphenhydramine Hydrochloride. There are 12 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Somnapure Clinical Strength 50 mg/1?

The NDC (National Drug Code) for Somnapure Clinical Strength 50 mg/1 is 69721-005, listed by Force Factor Brands LLC.

Product NDC

69721-005

Package NDC

69721-005-30

Other Diphenhydramine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)