FDA Label for Cramp Tabs
View Indications, Usage & Precautions
Cramp Tabs Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
symptoms do not improve
new symptoms occur
pain gets worse or lasts for more than 10 days
redness or swelling is present
Stop use and ask a doctor if:
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.
Package Label.Principal Display Panel
* Please review the disclaimer below.
