CRAMP TABS- cramp tablets tablet

Cramp Tabs by

Drug Labeling and Warnings

Cramp Tabs by is a Otc medication manufactured, distributed, or labeled by Redicare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRAMP TABS 
cramp tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71105-700
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6)	PAMABROM	25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white (Snow white)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	FEM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71105-700-68	100 in 1 CARTON; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/01/2017

Labeler - Redicare LLC (800149346)

Establishment
Name	Address	ID/FEI	Business Operations
Redicare LLC		800149346	repack(71105-700)