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SPL v1

SPL

SPL Set ID f2e9fbc8-501f-c386-e053-2995a90a6a14

Route

ORAL

Published

Effective Date 2023-01-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Caffeine (20 mg) Meclizine (25 mg) Pyridoxine (5 mg)

Inactive Ingredients

Glycerin

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2023-01-23

Description

Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride

Medication Information

Warnings and Precautions

Ask a doctor before use if you have taking a prescription drug.

When using this product

■ Do not take more than 3 pack in 24 hours

■ If you take an additional dose, take it after 4 hours or more

Keep out of reach of children

Indications and Usage

■ adult and children 15 years of age and older: 1 pack 30 minutes before boarding.

■ children under 15 years of age: ask a doctor

Dosage and Administration

for oral use

Description

Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride

Section 50565-1

Keep out of reach of children

Section 51727-6

concentrated glycerin, malt syrup, high fructose 55

Section 51945-4

Section 55105-1

■ throw up■ whirl ■ headache

Section 55106-9

Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride

Structured Label Content

Indications and Usage (34067-9)

■ adult and children 15 years of age and older: 1 pack 30 minutes before boarding.

■ children under 15 years of age: ask a doctor

Dosage and Administration (34068-7)

for oral use

Warnings and Precautions (34071-1)

Ask a doctor before use if you have taking a prescription drug.

When using this product

■ Do not take more than 3 pack in 24 hours

■ If you take an additional dose, take it after 4 hours or more

Keep out of reach of children

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

concentrated glycerin, malt syrup, high fructose 55

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ throw up■ whirl ■ headache

Section 55106-9 (55106-9)

Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "6", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MECLIZINE", "unii": "3L5TQ84570", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "6", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PYRIDOXINE", "unii": "KV2JZ1BI6Z", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "6", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "■ adult and children 15 years of age and older: 1 pack 30 minutes before boarding. ■ children under 15 years of age: ask a doctor", "34068-7": "for oral use", "34071-1": "Ask a doctor before use if you have taking a prescription drug. When using this product ■ Do not take more than 3 pack in 24 hours ■ If you take an additional dose, take it after 4 hours or more Keep out of reach of children", "50565-1": "Keep out of reach of children", "51727-6": "concentrated glycerin, malt syrup, high fructose 55", "55105-1": "■ throw up■ whirl ■ headache", "55106-9": "Caffeine Anhydrous, Meclizine Hydrochloride Hydrate, Pyridoxine Hydrochloride"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:30.043830 · Updated: 2026-03-14T23:00:57.322924