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Cramp Tabs by Redicare LLC

Dosage form: tablet
Ingredients: PAMABROM 25mg, ACETAMINOPHEN 325mg
Labeler: Redicare LLC
NDC Code: 71105-700

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cramp Tabs

Active Ingredients (in each tablet) Purpose

Acetaminophen 325 mg.............................................................................................................pain reliever/fever reducer

Pamabrom 25 mg....................................................................................................................................................diuretic

Uses:

For the relief of ■ cramps ■ a headache ■ bloating ■ backaches ■ water-weight gain ■ muscular aches and pains

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 ■ for more than 3 days for fever 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 ■ pain gets worse or lasts for more than 10 days ■ new symptoms occur ■ redness or swelling is present

If pregnant or breast-feeding a baby,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

In case of an 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.

Directions:

Adults and children 12 years of age or older: Take 2 Tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours or as directed by a doctor.
Children under 12 years of age: Consult a doctor.

Other Information:

■ Tamper Evident. Do not use if packet is torn, cut or opened

■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)

■ Avoid excessive heat and humidity

Inactive Ingredients:

Corn Starch, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, and Stearic Acid.

CRAMP TABS 
cramp tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-700
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PAMABROM (BROMOTHEOPHYLLINE) PAMABROM25 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STARCH, CORN 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A CORN 
Product Characteristics
Colorwhite (Snow white) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeFEM
Contains    
Packaging
#Item CodePackage Description
1NDC:71105-700-68100 TABLET in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/01/2017
Labeler - Redicare LLC (800149346)
Establishment
NameAddressID/FEIOperations
Redicare LLC800149346repack(71105-700)

 
Redicare LLC

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Medically reviewed on Feb 6, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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