DIPHENHYDRAMINE HCL 25 MG- diphenhydramine hcl capsule

Diphenhydramine HCl 25 mg by

Drug Labeling and Warnings

Diphenhydramine HCl 25 mg by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 DOCTOR

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 DOCTOR/PHARMACIST

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

Drug Facts continued of back of label

WHEN USING

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 years: do 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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

SPL UNCLASSIFIED SECTION

Drug Facts

PRINCIPAL DISPLAY PANEL

DRUG: Diphenhydramine HCl 25 mg

GENERIC: Diphenhydramine HCl

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1259-0

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: AP;20

PACKAGING: 20 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

• DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

• BENZYL ALCOHOL
• BUTYLPARABEN
• FD&C BLUE NO. 1
• D&C RED NO. 28
• FD&C RED NO. 40
• LACTOSE
• GELATIN
• METHYLPARABEN
• SODIUM LAURYL SULFATE
• MAGNESIUM STEARATE
• POLYSORBATE 80
• PROPYLPARABEN

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL 25 MG 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-1259(NDC:69618-024)
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GELATIN (UNII: 2G86QN327L)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	pink (Half pink and half white)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	AP;20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-1259-0	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/14/2018

Labeler - REMEDYREPACK INC. (829572556)