CRAMP TABS- acetaminophen, pamabrom tablet

Cramp Tabs by

Drug Labeling and Warnings

Cramp Tabs by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PREGNANCY OR BREAST FEEDING

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRAMP TABS 
acetaminophen, pamabrom tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-700
Route of Administration	ORAL

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

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: 67060-700-68	100 in 1 CARTON	08/10/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/10/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-700)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-700)