Label: DIPHENHYDRAMINE HCL tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 67296-1426-7 - Packager: RedPharm Drug, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0536-1214
- 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.
Drug Label Information
Updated March 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- to make a child sleepy
- 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
- difficulty in urination due to enlargement of the prostate gland
- to make a child sleepy
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
Rugby ®
NDC 0536-1214-29
COMPARE TO THE
ACTIVE INGREDIENT IN
BENADRYL ®
ALLERGY ULTRATAB ® TABLETS*Diphenhydramine HCl, 25 mg
Antihistamine
Allergy ReliefRelieves Sneezing,
Runny Nose, Itchy throat
& Itchy, Watery Eyes100 TABLETS
Actual SizeEasy to Swallow
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Johnson & Johnson Corporation,
owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844 ORG101632912
Distributed by: Rugby Laboratories, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152
www.rugbylaboratories.comRev.02/19 R-17 Re-order No. 370672
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DIPHENHYDRAMINE HCL
diphenhydramine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1426(NDC:0536-1214) 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 STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) Product Characteristics Color pink Score no score Shape OVAL Size 11mm Flavor Imprint Code 44;329 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67296-1426-7 24 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/28/2019 Labeler - RedPharm Drug, Inc. (828374897) Establishment Name Address ID/FEI Business Operations EPM Packaging, Inc. 079124340 repack(67296-1426) , label(67296-1426)