DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
ST. MARY'S MEDICAL PARK PHARMACY

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0835K- Major

Drug Facts

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

Purpose
Antihistamine

Uses

 temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  runny nose  sneezing  itchy, watery eyes  itching of the nose or throat

 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
 trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

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 (1-800-222-1222).

Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children
12 years of age and over
1 to 2 capsules
children 6 to
under 12 years of age
1 capsule
children under 6 years of agedo not use this product
in children under 6 years of age

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

D

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60760-697(NDC:0904-7237)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (Half pink and half clear with white powder inside and sealed with red band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60760-697-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/14/2022
Labeler - ST. MARY'S MEDICAL PARK PHARMACY (063050751)
Establishment
NameAddressID/FEIBusiness Operations
ST. MARY'S MEDICAL PARK PHARMACY063050751relabel(60760-697) , repack(60760-697)

Revised: 12/2023
Document Id: 0ccbb268-ec5a-c8eb-e063-6394a90a44b4
Set id: 0ccbc301-6833-bbc4-e063-6294a90aad92
Version: 1
Effective Time: 20231218
 
ST. MARY'S MEDICAL PARK PHARMACY