1006-major

1006-major
SPL v4
SPL
SPL Set ID 78d22836-a442-7c0c-e053-2991aa0a62f3
Route
ORAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlortheophylline (50 mg)
Inactive Ingredients
Croscarmellose Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 1006;1006 Shape: round Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-02-14 Until 2028-08-31

Description

Active ingredient (in each tablet) Dimenhydrinate 50 mg


Medication Information

Warnings and Precautions

Do not give to children under 2 years of age unless directed by a doctor

Description

Active ingredient (in each tablet) Dimenhydrinate 50 mg

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®.

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5

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

Section 50569-3

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

Section 51727-6

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4

MAJOR ®

NDC 0904-6772-12

Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

Driminate TM

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets 50mg Each

Use as Directed

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

.

Section 55105-1

Purpose

Antiemetic

Directions

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity

adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor

children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor

children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Other Information

■ each tablet contains: calcium 30 mg

■ store in a dry place at 15° – 30°C (59° – 86°F)

■ protect from moisture

■ see end -ap for expiration date and lot number

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

Questions Or Comments?

1-800-231-4670


Structured Label Content

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Warnings and Precautions (34071-1)

Do not give to children under 2 years of age unless directed by a doctor

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 42229-5 (42229-5)

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®.

Distributed by: MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Questions or comments?

Call (800) 616-2471

www.majorpharmaceuticals.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

■ marked drowsiness may occur

■ avoid alcoholic drinks

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4 (51945-4)

MAJOR ®

NDC 0904-6772-12

Compare to the Active Ingredient in DRAMAMINE ® Original Formula*

Driminate TM

Dimenhydrinate USP, Antiemetic

For Nausea, Dizziness and Vomiting from Motion Sickness

12 Tablets 50mg Each

Use as Directed

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

.

Section 55105-1 (55105-1)

Purpose

Antiemetic

Directions

■ to prevent motion sickness, the rst dose should be taken one-half to one hour before starting activity

adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor

children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor

children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

Drug Facts

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Other Information (Other information)

■ each tablet contains: calcium 30 mg

■ store in a dry place at 15° – 30°C (59° – 86°F)

■ protect from moisture

■ see end -ap for expiration date and lot number

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

Questions Or Comments? (Questions or comments?)

1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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