drug facts

drug facts
SPL v14
SPL
SPL Set ID cf79ac74-017e-4fb4-85d3-4ea944080e89
Route
oral
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
meclizine (25 mg)
Inactive Ingredients
croscarmellose sodium dextrose fd&c red no. 40 magnesium stearate cellulose, microcrystalline silicon dioxide saccharin sodium stearic acid raspberry

Identifiers & Packaging

Pill Appearance
Imprint: PH051 Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
otc monograph drug active Since 2018-02-01

Purpose

Antiemetic

Description

Meclizine HCl 25mg


Medication Information

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

Do not take this product unless directed by a doctor if you have

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

Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.

Active Ingredient

Meclizine HCl 25mg

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Purpose

Antiemetic

Directions
  • doage should be taken one hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other Information
  • Tamper Evident:do not use if seal is broken or missing from bottle.
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Description

Meclizine HCl 25mg

Section 51945-4

MECLIZINE

CHEWABLE

Raspberry Flavor

Questions Or Comments?

(866) 562-2756 (Mon - Fri, 8AM - 4PM EST)

When Using This Product
  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery
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)


Structured Label Content

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

Do not take this product unless directed by a doctor if you have

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

Do not take this product if you aretaking sedatives or tranquilizers, without first consulting your doctor.

Active Ingredient (Active ingredient (in each tablet))

Meclizine HCl 25mg

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Purpose

Antiemetic

Directions
  • doage should be taken one hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other Information (Other information)
  • Tamper Evident:do not use if seal is broken or missing from bottle.
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Section 51945-4 (51945-4)

MECLIZINE

CHEWABLE

Raspberry Flavor

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon - Fri, 8AM - 4PM EST)

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery
If Pregnant 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 (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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