Diphenhydramine Hcl Tablets 25 Mg Pink

Diphenhydramine Hcl Tablets 25 Mg Pink
SPL v1
SPL
SPL Set ID 0f140474-06ef-4cff-a290-3c1dae1ac65f
Route
ORAL
Published
Effective Date 2010-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Cellulose, Microcrystalline Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Croscarmellose Sodium Magnesium Stearate Polyethylene Glycol Polyvinyl Alcohol Titanium Dioxide Water D&c Red No. 27

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: oval Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-03-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks
  • excitability may occur, especially in children
Section 50568-5

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

Section 50569-3

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Section 50570-1

Do not use with any other product containing diphenhydramine, even one used on skin

Section 53414-9

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

Directions
  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age
Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Principal Display Panel 25 Mg Label

DIPHENHYDRAMINE HCL TABLETS 25 mg PINK

Each Film coated Tablet Contains:


DIPHENHYDRAMINE HCL 25 MG

Lot No : Jar No. :
MFG. DATE : Quantity : 100,000 Tablets
Exp. Date : NDC. No : 65437-036-10

WARNING :

KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT

CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:

MANUFACTURED CODE No Guj/Drugs/G/1362

LABELER CODE # 14803

MANUFACTURED FOR:

HIMPRIT PHARMACHEM PVT. LTD

"LAKULISH", R.V.DESAI ROAD,

NEXT TO NAVAPURA POLICE STATION

BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"


Structured Label Content

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
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • avoid alcoholic drinks
  • excitability may occur, especially in children
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)

Do not use with any other product containing diphenhydramine, even one used on skin

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Principal Display Panel 25 Mg Label (PRINCIPAL DISPLAY PANEL - 25 mg Label)

DIPHENHYDRAMINE HCL TABLETS 25 mg PINK

Each Film coated Tablet Contains:


DIPHENHYDRAMINE HCL 25 MG

Lot No : Jar No. :
MFG. DATE : Quantity : 100,000 Tablets
Exp. Date : NDC. No : 65437-036-10

WARNING :

KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT

CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:

MANUFACTURED CODE No Guj/Drugs/G/1362

LABELER CODE # 14803

MANUFACTURED FOR:

HIMPRIT PHARMACHEM PVT. LTD

"LAKULISH", R.V.DESAI ROAD,

NEXT TO NAVAPURA POLICE STATION

BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"


Advanced Ingredient Data


Raw Label Data

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