Allergy Get Relief

Allergy Get Relief
SPL v1
SPL
SPL Set ID 9b5747d9-76fd-4f13-8a22-cd5d13e1df2f
Route
ORAL
Published
Effective Date 2012-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Hypromelloses Lactose Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycols Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;048 Shape: oval Color: pink Size: 11 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-30

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:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • and these symptoms associated with the common cold:
    • sneezing
    • runny nose
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 50570-1

Do not use with any other products containing diphenhydramine, including 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 doses in 24 hours
Adults and children 12 years of age and over 1 to 2 caplets
Children 6 to under 12 years 1 caplet
Children under 6 years Consult a doctor
Overdose Warning

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Other Information
  • store between 20-25 C (68-77 F).Avoid high humidity. Protect from light
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date
Inactive Ingredients

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. May contain polysorbate.

Questions Or Comments?

Call toll free 1-800-570-8650 (M-F 9 am to 5 pm PST)

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma or
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 50 Pouch Carton

Compare to the Active Ingredients in

Bendaryl ® Allergy*

Allergy

Get Relief

  • Itchy, Watery Eyes
  • Itchy Throat
  • Sneezing
  • Runny Nose

Diphenhydramine Hci, An Antihistamine


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • and these symptoms associated with the common cold:
    • sneezing
    • runny nose
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 50570-1 (50570-1)

Do not use with any other products containing diphenhydramine, including 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 doses in 24 hours
Adults and children 12 years of age and over 1 to 2 caplets
Children 6 to under 12 years 1 caplet
Children under 6 years Consult a doctor
Overdose Warning (Overdose warning)

In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Other Information (Other information)
  • store between 20-25 C (68-77 F).Avoid high humidity. Protect from light
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. May contain polysorbate.

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-570-8650 (M-F 9 am to 5 pm PST)

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma or
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 50 Pouch Carton (PRINCIPAL DISPLAY PANEL - 50 Pouch Carton)

Compare to the Active Ingredients in

Bendaryl ® Allergy*

Allergy

Get Relief

  • Itchy, Watery Eyes
  • Itchy Throat
  • Sneezing
  • Runny Nose

Diphenhydramine Hci, An Antihistamine


Advanced Ingredient Data


Raw Label Data

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