MECLIZINE HYDROCHLORIDE tablet, chewable MECLIZINE HCL tablet, chewable

MECLIZINE HCL by

Drug Labeling and Warnings

MECLIZINE HCL by is a Otc medication manufactured, distributed, or labeled by DIRECTRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

PURPOSE

Antiemetic

INDICATIONS & USAGE

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

WARNINGS

Warnings

Do not use in children under 12 years of age unless directed by a 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 a doctor or pharmacist before use it you are taking sedatives or tranquilizers.

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

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 the poison control center immediately.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

INACTIVE INGREDIENT

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

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

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

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-454(NDC:0536-1018)
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
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SUCROSE (UNII: C151H8M554)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND (Biconvex Uncoated Tablet with Bisect)	Size	8mm
Flavor		Imprint Code	21G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-454-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	04/10/2019

MECLIZINE HCL 
meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-641(NDC:49483-333)
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  in 25

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DEXTROSE (UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
VANILLA (UNII: Q74T35078H)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY	Imprint Code	TCL333
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-641-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	04/10/2019

Labeler - DIRECTRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECTRX		079254320	repack(61919-454, 61919-641)