Label: ONLY FOR SLEEP- diphenhydramine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 73006-111-41 - Packager: O4 Global Trading Usa, Llc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 25, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient (in each caplet)
- Purpose
- Uses:
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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
- trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you
are taking sedatives or tranquilizersWhen using this product
- avoid alcoholic drinks
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.If pregnant or breast-feeding,
ask a health professional before use. - Directions:
- Other Information:
- Inactive Ingredients:
- Questions Or Comments ?
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SPL UNCLASSIFIED SECTION
NDC: 73006-111-41
NIGHTTIME SLEEP-AID
Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.
Tear along perforation push product through foil
- Packaging
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INGREDIENTS AND APPEARANCE
ONLY FOR SLEEP
diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-111 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C BLUE NO. 4 (UNII: 0KSY80VYS3) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) ISOPROPYL ALCOHOL (UNII: ND2M416302) MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL (CAPLET) Size 12mm Flavor Imprint Code S1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-111-41 1 in 1 CARTON 03/29/2019 1 4 in 1 BLISTER PACK; 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 03/29/2019 Labeler - O4 Global Trading Usa, Llc (081226861)