1006-acme

1006-acme
SPL v2
SPL
SPL Set ID 7b32c52a-f2b0-4acc-e053-2a91aa0a5bcc
Route
ORAL
Published
Effective Date 2019-04-18
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 FINAL Active Since 2019-04-18

Description

Active Ingredient (in each tablet) Dimenhydrinate 50 mg


Medication Information

Description

Active Ingredient (in each tablet) Dimenhydrinate 50 mg

Uses

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

Section 34088-5

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

Section 42229-5

Retain carton for complete product information

Manufactured for:

Acme United Corporation

55 Walls Dr, Fairfield, CT 06824

www.FirstAidOnly.com

Made in the USA

©2018 Acme United Corporation

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product

  • marked drowsiness may occir
  • avoid alcoholic drinks
  • alcohol, sedatives and traquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

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

Section 50569-3

Ask doctor before use if you have

  • breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.
Section 50570-1

Do not use in children under 2 years of age unless directed by a doctor

Section 51727-6

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4

Physician Care®

Motion Sickness

Dimenhydrinate/ Antiemetic

Nausea, Vomiting and Dizziness Relief

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Dimenhydrinate 50mg

100 Tablets (50 Packets, 2 Tablets each)

Section 53414-9

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

Section 55105-1

Purpose

Antiemetic

Directions

To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.

To prevent or treat motion sickness:

Adults and Children (12 years and older) take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor.
Children 6 to under 12 years give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor.
Children 2 to under 6 years give ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor

Drug Facts

Active Ingredient (in each tablet)

Dimenhydrinate 50 mg

Questions?

1-800-835-2263

Other Information
  • each tablet contains calcium 29 mg
  • store at room temperature
  • do not use if packet is open or torn

Structured Label Content

Uses

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

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Retain carton for complete product information

Manufactured for:

Acme United Corporation

55 Walls Dr, Fairfield, CT 06824

www.FirstAidOnly.com

Made in the USA

©2018 Acme United Corporation

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occir
  • avoid alcoholic drinks
  • alcohol, sedatives and traquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask doctor before use if you have

  • breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.
Section 50570-1 (50570-1)

Do not use in children under 2 years of age unless directed by a doctor

Section 51727-6 (51727-6)

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

Section 51945-4 (51945-4)

Physician Care®

Motion Sickness

Dimenhydrinate/ Antiemetic

Nausea, Vomiting and Dizziness Relief

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Dimenhydrinate 50mg

100 Tablets (50 Packets, 2 Tablets each)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antiemetic

Directions

To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.

To prevent or treat motion sickness:

Adults and Children (12 years and older) take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor.
Children 6 to under 12 years give 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor.
Children 2 to under 6 years give ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor

Drug Facts

Active Ingredient (in each tablet)

Dimenhydrinate 50 mg

Questions?

1-800-835-2263

Other Information (Other information)
  • each tablet contains calcium 29 mg
  • store at room temperature
  • do not use if packet is open or torn

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)