Label: SLEEP AID- diphenhydramine hcl capsule
- NDC Code(s): 55319-735-32
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 15, 2018
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- Active ingredient (in each softgel)
Diphenhydramine HCl 50 mgClose
for relief of occasional sleeplessness.Close
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
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
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.
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).
- adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
- Other information
- store between 15-30ºC (59-86ºF)
- Inactive ingredients
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol-sorbitan
*contains one or more of these ingredientsClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®†
Diphenhydramine HCl, 50 mg
Help to Reduce Difficulty Falling Asleep
†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS NC 2810Close
- Product Label
FAMILY WELLNESS Sleep-Aid
- INGREDIENTS AND APPEARANCE
diphenhydramine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-735 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 13mm Flavor Imprint Code P50;A99;D50;AP018 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-735-32 1 in 1 BOX 09/30/2018 1 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 09/30/2018 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)