Label: SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule
- NDC Code(s): 41520-231-32, 41520-231-40
- Packager: Care One (American Sales Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each softgel)
Diphenhydramine HCl 50 mgClose
- helps to reduce difficulty falling asleep
Do not give to children under 12 years of age.Close
- Do not use this product
- With other products containing diphenhydramine, even one used on skin.
- Ask a doctor before use if you have
- chronic bronchitis
- difficulty in urination due to an enlargement of the prostate gland
- When using this product
avoid alcoholic beveragesClose
- Stop use and ask a doctor if
- sleeplessness persists 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 right away.
- adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
- Other information
- Store at controlled room temperature 15°-30°C (59°-86°F)
- do not use if imprinted safety seal under cap is broken or missing
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®
- Inactive ingredients
edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special. Close
- Principal Display Panel
Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®*
Helps to reduce difficulty falling asleep
Diphenhydramine HCl 50 mg
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Distributed by: American Sales Company
4201 walden avenue, Lancaster, NY 14086
© 2009 S&S BRANDS, INC.
Quality guaranteed or your money backClose
- Product Label
Diphenhydramine HCl 50 mg
- INGREDIENTS AND APPEARANCE
SLEEP AID MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-231 Route of Administration ORAL DEA Schedule 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 GLYCOLS (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 13mm Flavor Imprint Code P50;A99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-231-32 1 in 1 CARTON 1 32 in 1 BOTTLE 2 NDC:41520-231-40 1 in 1 BOX 2 40 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/01/2010 Labeler - Care One (American Sales Company) (809183973) Registrant - P and L Development of New York Corporation (800014821)