Bonine®

Bonine®
SPL v6
SPL
SPL Set ID 2c6f014d-6d46-4f8a-9196-904639dcb899
Route
ORAL
Published
Effective Date 2022-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose 101 Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: WS1 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-05-01 Until 2026-04-30

Description

Diphenhydramine HCl 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Diphenhydramine HCl 25 mg

Uses

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

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN. Keep Carton for important drug facts information.

Distributed by: WellSpring

Pharmaceutical Corporation

Sarasota, FL 34243

©2023 WellSpring

Pharmaceutical Corporation

Money Back Guarantee

Directions

■ dosage should be taken 30 minutes before you begin motion activity.

■ adults and children 12 years and over: take 1 to 2 tablets with Water every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.

■ Children 6 to under 12 years of age: take 1 tablet with Water every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.

Do Not Use

■ for children under 6 years of age unless

■ Do not use with any other product containing diphenhydramine, including one used on skin

Questions?

1-844-241-5454 or www.bonine.com

Other Information

■ Each tablet contains: Calcium 60mg 

■ Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F)

■ protect from moisture

■ see end flap for expiration date and lot number

Inactive Ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1, aluminum lake, magnesium stearate, microcrystalline cellulose, silicone dioxide, stearic acid

When Using This Product

 marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic beverages

■ use caution 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.

Active Ingredient (in Each Tablet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

■ difficulty in urination due to enlargement of the prostate gland

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 65197 616 16

NEW

9X the Adventure**

Diphenhydramine HCl - Antiemetic 25 mg

Prevents & Treats:

Vomiting  •  Nausea  •  Dizziness • Motion Sickness

*See back panel reference

* Than Meclizine HCL 25 mg per onset of action from The U.S. National Library of Medicine (NLM)

** Results may vary

FASTER-ACTING* RELIEF

TAKE WITH WATER

Bonine Faster Acting 2.0
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN. Keep Carton for important drug facts information.

Distributed by: WellSpring

Pharmaceutical Corporation

Sarasota, FL 34243

©2023 WellSpring

Pharmaceutical Corporation

Money Back Guarantee

Purpose

Antiemetic

Directions

■ dosage should be taken 30 minutes before you begin motion activity.

■ adults and children 12 years and over: take 1 to 2 tablets with Water every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.

■ Children 6 to under 12 years of age: take 1 tablet with Water every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.

Do Not Use (Do not use)

■ for children under 6 years of age unless

■ Do not use with any other product containing diphenhydramine, including one used on skin

Questions?

1-844-241-5454 or www.bonine.com

Other Information (Other information)

■ Each tablet contains: Calcium 60mg 

■ Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F)

■ protect from moisture

■ see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1, aluminum lake, magnesium stearate, microcrystalline cellulose, silicone dioxide, stearic acid

When Using This Product (When using this product)

 marked drowsiness may occur

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic beverages

■ use caution when driving a motor vehicle or operating machinery

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ difficulty in urination due to enlargement of the prostate gland

■ glaucoma

■ difficulty in urination due to enlargement of the prostate gland

Principal Display Panel 65197 616 16 (PRINCIPAL DISPLAY PANEL 65197-616-16)

NEW

9X the Adventure**

Diphenhydramine HCl - Antiemetic 25 mg

Prevents & Treats:

Vomiting  •  Nausea  •  Dizziness • Motion Sickness

*See back panel reference

* Than Meclizine HCL 25 mg per onset of action from The U.S. National Library of Medicine (NLM)

** Results may vary

FASTER-ACTING* RELIEF

TAKE WITH WATER

Bonine Faster Acting 2.0
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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