MECLIZINE HCL 25 MG tablet, chewable

Meclizine HCl 25 mg by

Drug Labeling and Warnings

Meclizine HCl 25 mg by is a Otc medication manufactured, distributed, or labeled by RedPharm Drug, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)

Meclizine HCl, USP 25 mg

PURPOSE

Antiemetic

USES

prevents and treats nausea, vomiting or dizziness due to motion sickness

WARNINGS

WARNINGS

DO NOT USE

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

ASK DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

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

PREGNANCY 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 the poison control center immediately.

DIRECTIONS

Dosage should be taken one hour before travel starts.
Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

OTHER INFORMATION

store at room temperature

OTHER SAFETY INFORMATION

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

QUESTIONS OR COMMENTS?

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

WHEN USING

When using this product

may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution when driving a motor vehicle or operating machinery

PURPOSE

Antiemetic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG 
meclizine hcl 25 mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67296-1390(NDC:51645-994)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)

Product Characteristics
Color	pink (uncoated)	Score	2 pieces
Shape	ROUND (bioconvex)	Size	8mm
Flavor	RASPBERRY	Imprint Code	21G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67296-1390-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	10/15/2015

Labeler - RedPharm Drug, Inc. (828374897)

Establishment
Name	Address	ID/FEI	Business Operations
RedPharm Drug, Inc.		828374897	repack(67296-1390) , relabel(67296-1390)