BONINE- meclizine hydrochloride tablet, chewable

BONINE by

Drug Labeling and Warnings

BONINE by is a Otc medication manufactured, distributed, or labeled by WellSpring Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

Warnings

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

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

When using this product

• do not exceed recommended dosage
• you may get drowsy
• 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 1 (800) 222-1222

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

Other information

store at room temperature 20°– 25°C (68°–77°F)

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.

Questions?

call toll-free 1 (844) 241-5454 or visit us on the web at www.bonine.com

SPL UNCLASSIFIED SECTION

ATTENTION:  DO NOT USE IF CARTON IS OPEN OR IF BLISTER IS TORN OR MISSING. 

Dist. by: WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA © WellSpring 2014

PRINCIPAL DISPLAY PANEL 65197-275

Bonine 16 ct

Principal Display Panel 65197-296

INGREDIENTS AND APPEARANCE

BONINE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65197-275
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
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	PINK (light pink)	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY, VANILLA	Imprint Code	Bonine;201
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65197-275-08	1 in 1 BOX	12/15/2014
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 65197-275-16	2 in 1 BOX	12/15/2014
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 65197-275-12	1 in 1 BOX	12/15/2014
3		12 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 65197-275-02	2 in 1 POUCH; Type 0: Not a Combination Product	12/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	12/15/2014

BONINE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65197-296
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY	Imprint Code	Bonine;201
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65197-296-08	1 in 1 BOX	04/19/2017
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 65197-296-16	2 in 1 BOX	04/19/2017
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	04/18/2017

Labeler - WellSpring Pharmaceutical Corporation (110999054)