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Diphenhydramine HCl 25 mg by Reliable 1 Laboratories LLC

Medically reviewed on Nov 1, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-024

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.

Diphenhydramine HCL 25 mg Capsules

Active ingredient (in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses

temporarily releaves these symptoms of hay fever or other upper respiratory allergies:

  • runny nose
  • itchy nose or throat
  • sneezing
  • itchy, watery eyes

Warnings

Do not use

  • with any otherprodcut containing diphenhydramine, even one use on skin
  • to make a child sleepy

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharamcist before use if you are taking sedatives or tranquilizers

Drug Facts continued of back of label

When using this product

  • you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, & 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.

Directions
  • take every 4-6 hours
  • do not take more than 6 doses in 24 hours

adults and children 12 years and over

1 to 2 capsules

children 6 to under 12 years

1 capsule

children under 6 yearsdo not use

Other information
  • store at room temperature
  • protect from moisture

Inactive ingredients

benzl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methlyparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS BROKEN OR MISSING

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

Drug Facts

NDC 69618-024-01

Diphenhydramine HCL 25 mg

ANTIHISTAMINE

100 CAPSULES

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-024
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
METHYLPARABEN 
SODIUM LAURYL SULFATE 
GELATIN 
POLYSORBATE 80 
PROPYLPARABEN 
BENZYL ALCOHOL 
BUTYLPARABEN 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
LACTOSE 
MAGNESIUM STEARATE 
Product Characteristics
Colorpink (Half pink and half white) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeAP;20
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-024-01100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/01/2015
Labeler - Reliable 1 Laboratories LLC (079718111)

 
Reliable 1 Laboratories LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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