OTC Medication Information: Sleep Aid Nighttime

SLEEP AID NIGHTTIME- diphenhydramine hydrochloride capsule
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

For relief of occasional sleeplessness.

Warnings

Do not use

  • for 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

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

avoid alcoholic drinks

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 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 (1-800-222-1222) right away

Directions

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

Other information

  • store between 15-30ºC (59-86ºF)

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Unisom® SleepGels®*†

MAXIMUM STRENGTH

Nighttime

Sleep Aid

DIPHENHYDRAMINE HCL, 50 mg

Nighttime Sleep-Aid

Non-habit forming

SOFTGELS

(One Softgel Per Dose)

†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

Diphenhydramine HCL 50 mg
(click image for full-size original)

CVS HEALTH Maximum Strength Nighttime Sleep Aid

SLEEP AID NIGHTTIME
diphenhydramine hcl capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-916
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
LECITHIN, SOYBEAN
WATER
SORBITOL
SORBITAN
LIGHT MINERAL OIL
MANNITOL
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code PC5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-916-32 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 32 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the BOX (69842-916-32)
2 NDC:69842-916-96 96 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:69842-916-64 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
3 64 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the BOX (69842-916-64)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 11/29/2019
Labeler — CVS Pharmacy (062312574)

Revised: 11/2022 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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