Cramp Tabs
FDA Label NDC 67060-700

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Cramp Tabs (NDC 67060-700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - Purpose

PAIN RELIEVER/FEVER REDUCER WITH Diuretic

Indications & Usage

Uses: For the relief of:

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

Warnings

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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. Prompt medical attention is critical for

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

Dosage & 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.

Inactive Ingredient

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

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Advanced First Aid Cramp Tabs (Advanced1staidcramptabs)

Advanced First Aid Cramp Tabs (Advanced1staidcramptabs)

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