352r Target Dimenhydrinate 50 Mg Tablets

352r Target Dimenhydrinate 50 Mg Tablets
SPL v2
SPL
SPL Set ID 28586e9b-01e3-0b88-e063-6394a90af7e0
Route
ORAL
Published
Effective Date 2025-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
8-chlorotheophylline (50 mg)
Inactive Ingredients
Hypromellose, Unspecified Microcrystalline Cellulose Silicon Dioxide Croscarmellose Sodium Magnesium Stearate Mineral Oil Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Imprint: TCL352 Shape: round Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Dosage and Administration

Directions

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:

Adults and children 12 years and over ​

  • ​take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor

Children 6 to under 12 years

  • give ½ to 1 tablet every 6-8 hours
  • do not give more than 3 tablets in 24 hours, or as directed by a doctor

Children 2 to under 6 years

  • give ½ tablet every 6-8 hours
  • do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50567-7

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Section 51727-6

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

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

Section 55105-1

Purpose

Antiemetic

Section 55106-9

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Section 60561-8

Other information

  • SODIUM FREE
  • store at room temperature 20-25ºC (68-77ºF)
  • use by expiration date on package

Structured Label Content

Indications and Usage (34067-9)

Uses

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness
Dosage and Administration (34068-7)

Directions

  • to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity
  • to prevent or treat motion sickness, see below:

Adults and children 12 years and over ​

  • ​take 1 to 2 tablets every 4-6 hours
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor

Children 6 to under 12 years

  • give ½ to 1 tablet every 6-8 hours
  • do not give more than 3 tablets in 24 hours, or as directed by a doctor

Children 2 to under 6 years

  • give ½ tablet every 6-8 hours
  • do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor
Warnings and Precautions (34071-1)

Warnings

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50567-7 (50567-7)

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, mineral oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antiemetic

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Dimenhydrinate 50 mg

Section 60561-8 (60561-8)

Other information

  • SODIUM FREE
  • store at room temperature 20-25ºC (68-77ºF)
  • use by expiration date on package

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)