MOTION-TIME CHEWABLE- meclizine hcl tablet, chewable

Motion-Time by

Drug Labeling and Warnings

Motion-Time by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Meclizine HCl 25 mg

PURPOSE

Purpose

Antiemetic

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

Do not give to children under 12 years of age unless directed by a doctor

ASK DOCTOR

Do not take unless directed by a doctor if you have

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

DO NOT USE

Do not take if you are

taking sedatives or tranquilizers, without first consulting your doctor

WHEN USING

When using this product

• do not exceed recommended dosage
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

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 a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• dosage should be taken one hour before travel starts
• adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

STORAGE AND HANDLING

Other information

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
• use by expiration date on package

INACTIVE INGREDIENT

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

HOW SUPPLIED

Product: 71335-0821

NDC: 71335-0821-0 120 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-1 30 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-3 25 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-4 40 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-5 60 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-6 90 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-7 8 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-8 14 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-0821-9 10 TABLET, CHEWABLE in a BOTTLE

Meclizine 25MG Chewable

INGREDIENTS AND APPEARANCE

MOTION-TIME  CHEWABLE
meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-0821(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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
RASPBERRY (UNII: 4N14V5R27W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
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: 71335-0821-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
2	NDC: 71335-0821-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
3	NDC: 71335-0821-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
4	NDC: 71335-0821-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
5	NDC: 71335-0821-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
6	NDC: 71335-0821-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
7	NDC: 71335-0821-3	25 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
8	NDC: 71335-0821-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
9	NDC: 71335-0821-0	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018
10	NDC: 71335-0821-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	08/09/2010

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-0821) , RELABEL(71335-0821)