motion sickness relief

motion sickness relief
SPL v1
SPL
SPL Set ID 8d772ff0-1476-48ca-a7e4-9473ce3db83a
Route
oral
Published
Effective Date 2017-11-28
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 final active Since 2017-11-28

Purpose

Antiemetic

Description

Meclizine Hydrochloride 25 mg


Medication Information

Active Ingredient

Meclizine Hydrochloride 25 mg

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Purpose

Antiemetic

Directions
  • take first dose one hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
Other Information
  • Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
  • store at room temperature 15º - 30ºC (59º - 86ºF)
Inactive Ingredients

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

Description

Meclizine Hydrochloride 25 mg

Principal Display Panel

Motion Sickness Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC 51013-322-54

Do Not Use

for children under 12 years of age unless directed by a doctor

Questions Or Comments?

Call toll free: 1-855-215-8180

When Using This Product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding,

ask a doctor before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Meclizine Hydrochloride 25 mg

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Purpose

Antiemetic

Directions
  • take first dose one hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
Other Information (Other information)
  • Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
  • store at room temperature 15º - 30ºC (59º - 86ºF)
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Motion Sickness Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC 51013-322-54

Do Not Use (Do not use)

for children under 12 years of age unless directed by a doctor

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a doctor 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 (1-800-222-1222) right away.

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
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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