MECLIZINE- meclizine hcl 25mg tablet, chewable

MECLIZINE by

Drug Labeling and Warnings

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

Drug Details [pdf]

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).

HOW SUPPLIED

Product: 71335-1215

NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE

NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE

Meclizine 25MG Chewable

INGREDIENTS AND APPEARANCE

MECLIZINE 
meclizine hcl 25mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1215(NDC:66424-387)
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)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)

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	Marketing Start Date	Marketing End Date
1	NDC: 71335-1215-0	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
2	NDC: 71335-1215-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
3	NDC: 71335-1215-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
4	NDC: 71335-1215-3	25 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
5	NDC: 71335-1215-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
6	NDC: 71335-1215-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
7	NDC: 71335-1215-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
8	NDC: 71335-1215-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
9	NDC: 71335-1215-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019
10	NDC: 71335-1215-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	02/01/2018

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-1215) , RELABEL(71335-1215)