SPL v1
SPL
SPL Set ID 3e6822a7-58ff-4778-a24e-7d9e8ecb1d33
Route
ORAL
Published
Effective Date 2015-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 1) Bromotheophylline (25 1)
Inactive Ingredients
Cellulose, Microcrystalline Povidone K30 Starch, Corn Stearic Acid Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-10
Description

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, pamabrom 25 MG

Medication Information

Warnings and Precautions

Warnings:

Liver Warning:

This product contains Acetaminophen. Severe liver damage may occur if:

•you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription

or non-prescription)

• you have 3 or more alcoholic drinks every day while using this product

Precaution: If a rare sensitivity reaction occurs, the drug should be discontinued.

Do not use:

• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• for more than 10 days for pain unless directed by a doctor

  • than 3 days unless directed by a doctor

  • when using this product do not exceed recommended dose

Stop use and ask a doctor if:

  • symptoms do not improve

  • new symptoms occur

  • pain gets worse or lasts for more than 10 days

  • redness or swelling is present

Indications and Usage

Uses: For the relief of:

  • cramps
  • headache
  • bloating
  • backaches
  • water-weight gain
  • muscular aches and pains
Dosage and Administration

Adults and children 12 years of age and older:Take 2 tablets every 4-6 hours as

 needed. Do not exceed 8 tablets in any 24 hour period, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Description

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, pamabrom 25 MG

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or

contact a Poison Control Center right away. Prompt medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid.

Section 51945-4

Section 53414-9

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

Section 55105-1

PAIN RELIEVER/FEVER REDUCER WITH Diuretic

Section 55106-9

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, pamabrom 25 MG

Structured Label Content

Indications and Usage (34067-9)

Uses: For the relief of:

  • cramps
  • headache
  • bloating
  • backaches
  • water-weight gain
  • muscular aches and pains
Dosage and Administration (34068-7)

Adults and children 12 years of age and older:Take 2 tablets every 4-6 hours as

 needed. Do not exceed 8 tablets in any 24 hour period, or as directed by a doctor.

Children under 12 years: Consult a doctor.

Warnings and Precautions (34071-1)

Warnings:

Liver Warning:

This product contains Acetaminophen. Severe liver damage may occur if:

•you take more than 8 tablets in 24 hours • you take with other drugs containing acetaminophen (prescription

or non-prescription)

• you have 3 or more alcoholic drinks every day while using this product

Precaution: If a rare sensitivity reaction occurs, the drug should be discontinued.

Do not use:

• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

• for more than 10 days for pain unless directed by a doctor

  • than 3 days unless directed by a doctor

  • when using this product do not exceed recommended dose

Stop use and ask a doctor if:

  • symptoms do not improve

  • new symptoms occur

  • pain gets worse or lasts for more than 10 days

  • redness or swelling is present

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. Prompt medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive Ingredients: corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

PAIN RELIEVER/FEVER REDUCER WITH Diuretic

Section 55106-9 (55106-9)

ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 250 MG, pamabrom 25 MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:58.530261 · Updated: 2026-03-14T22:54:06.236353