drug facts

drug facts
SPL v3
SPL
SPL Set ID d304e205-85fa-494a-9a68-ae6855b139b1
Route
oral
Published
Effective Date 2019-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
meclizine (12.5 mg)
Inactive Ingredients
croscarmellose sodium calcium phosphate, dibasic, anhydrous magnesium stearate cellulose, microcrystalline silicon dioxide stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: PH049 Shape: capsule Color: white Size: 13 mm Score: 2
Marketing Status
otc monograph drug active Since 2019-07-08

Purpose

Antiemetic

Description

Meclizine HCl 12.5 mg


Medication Information

Uses

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

Purpose

Antiemetic

Directions
  • dosage should be taken one hour before travel starts
adults and children 12 years and over take 2 or 4 caplets once daily or as directed by a doctor 

Other Information
  • each caplet contains: calcium 28 mg
  • store at 20 o-25°C (68 o-77°F)
Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Description

Meclizine HCl 12.5 mg

Section 51945-4

PHARBEST

NDC 73057-386-11

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

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 are taking sedatives or tranquilizers, without first consulting your doctor.

Questions Or Comments?

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

When Using This Product
  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use causion 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).

Active Ingredient (in Each Caplet)

Meclizine HCl 12.5 mg


Structured Label Content

Uses

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

Purpose

Antiemetic

Directions
  • dosage should be taken one hour before travel starts
adults and children 12 years and over take 2 or 4 caplets once daily or as directed by a doctor 

Other Information (Other information)
  • each caplet contains: calcium 28 mg
  • store at 20 o-25°C (68 o-77°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Section 51945-4 (51945-4)

PHARBEST

NDC 73057-386-11

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

Do Not Use (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 are taking sedatives or tranquilizers, without first consulting your doctor.

Questions Or Comments? (Questions or comments?)

(866) 562-2756 (Mon-Fri 8 AM to 4 PM 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 causion 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).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Meclizine HCl 12.5 mg


Advanced Ingredient Data


Raw Label Data

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