Drugplain

Sleep Aid 50 mg/30mL

Diphenhydramine HCl · SOLUTION · Walgreen Company

9 Recalls on Record
Plain English

Sleep Aid is a solution containing diphenhydramine hcl at 50 mg/30mL, taken oral. Manufactured by Walgreen Company.

Key Facts

Brand Name
Sleep Aid
Generic Name
Diphenhydramine HCl
NDC Code (Product)
0363-8020
Manufacturer
Walgreen Company
Strength
50 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
03/10/2022

Recall History

9 Recalls on Record
Class II03/04/2025

Chattem Inc

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

OngoingVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class III08/04/2022

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use11,114 reports
fatigue8,417 reports
headache7,903 reports
drug ineffective7,280 reports
nausea7,166 reports
pain6,962 reports
infusion related reaction6,072 reports
arthralgia5,771 reports
toxicity to various agents5,497 reports
dyspnoea5,350 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 of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

Warnings

Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep 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 or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Sleep Aid used for?

Sleep Aid contains Diphenhydramine HCl. It is a solution taken oral. Consult your doctor for specific uses.

Is Sleep Aid a controlled substance?

Sleep Aid is not classified as a controlled substance by the DEA.

What is the generic name for Sleep Aid?

The generic name for Sleep Aid is Diphenhydramine HCl. There are 11 other brand versions of Diphenhydramine HCl.

What is the NDC code for Sleep Aid 50 mg/30mL?

The NDC (National Drug Code) for Sleep Aid 50 mg/30mL is 0363-8020, listed by Walgreen Company.