Motion Sickness

Motion Sickness
SPL v2
SPL
SPL Set ID 02d1af4d-d97d-4019-a5bf-3ec391238676
Route
ORAL
Published
Effective Date 2021-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Aspartame Croscarmellose Sodium Dextrose Fd&c Red No. 40 Raspberry Magnesium Stearate Microcrystalline Cellulose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: AP;115 Shape: round Color: red Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-01

Description

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine Hydrochloride 25 mg

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

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

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

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increse drowsiness
  • be careful when driving a moor vehicle or operating machinery
Directions

take dose one hour before travel starts

tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

  • take 1-2 tablets once daily

children under 12 years:

  • ask a doctor
Active Ingredient

Meclizine Hydrochloride 25 mg

Other Information

Phenylketonurics:

each tablet contains:

phenylalanine 0.28 mg

store at room temparature 15 - 30 °C

Inactive Ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions Or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 25 mg
30 71610-0528-30
90 71610-0528-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20210415JH

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Principal Display Panel 25 Mg

NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets


Structured Label Content

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Purpose

Antiemetic

Warnings

Ask a doctor before use if you have

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

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

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increse drowsiness
  • be careful when driving a moor vehicle or operating machinery
Directions

take dose one hour before travel starts

tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

  • take 1-2 tablets once daily

children under 12 years:

  • ask a doctor
Active Ingredient (Active ingredient)

Meclizine Hydrochloride 25 mg

Other Information (OTHER INFORMATION)

Phenylketonurics:

each tablet contains:

phenylalanine 0.28 mg

store at room temparature 15 - 30 °C

Inactive Ingredients (Inactive ingredients)

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions Or Comments (Questions or Comments)

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 25 mg
30 71610-0528-30
90 71610-0528-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20210415JH

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.

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

NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets


Advanced Ingredient Data


Raw Label Data

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