MECLIZINE: Package Insert and Label Information

MECLIZINE- meclizine hydrochloride tablet, chewable
RedPharm Drug, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

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

Warnings

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

Do not take unless directed by a doctor if you have

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

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful 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.

Directions

  • doage should be taken 1 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 safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions?

Adverse drug event call (800) 687-0176 (M — F, 8AM — 4PM EST).

NDC 66424-0387-01

*Compare to the active ingredient in Bonine ®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 TABLETS

SDA

LABORATORIES

SDA Meclizine 25 mg Tablet Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL

MECLIZINE
meclizine hcl 25mg tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1750(NDC:66424-387)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DEXTROSE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SACCHARIN SODIUM
STEARIC ACID
Product Characteristics
Color pink (LIGHT PINK COLOR) Score 2 pieces
Shape ROUND (ROUND TABLET) Size 8mm
Flavor Imprint Code PH051
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1750-3 30 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 01/01/2020
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
RedPharm Drug, Inc. 828374897 repack (67296-1750), relabel (67296-1750)

Revised: 01/2020 RedPharm Drug, Inc.

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