UNISHIELD CRAMP- acetaminophen, pamabrom tablet, film coated

Unishield Cramp by

Drug Labeling and Warnings

Unishield Cramp by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 325 mg

Pamabrom 25 mg

PURPOSE

Purpose

Pain reliever/fever reducer

Diuretic

INDICATIONS & USAGE

Uses

Temporarily relieves headache, bloating, cramps, backache, water-weight gain, muscular aches and pains associated with the menstrual period.

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

■ more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

DO NOT USE

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

ASK DOCTOR

Ask a doctor before use if you have

■ liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

WHEN USING

When using this product do not exceed recommended dose.

STOP USE

Stop use and ask a doctor if

■ symptoms do not improve

■ new symptoms occur

■ pain or fever persists or gets worse

■ redness or swelling is present

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, 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

Directions

■ drink 6 to 8 glasses of water each day while you are taking the tablets

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ avoid excessive heat and humidity

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose,

povidone, starch, stearic acid, sucrose

QUESTIONS

Questions or comments? 800-480-5856

Unishield Cramp Tabs

Unishield

Cramp Tabs

Menstrual Relief

100 Tablets/ 1 Tablet Per Packet

Acetaminophen 325 mg

Pamabrom 25 mg

Pull To Open

This Package is for Households without Young Children.

Reduces water-weight gain

Relieves headaches, backaches and muscular aches & pains

Relieves Cramps and Bloating

Tamper Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

UNISHIELD CRAMP 
acetaminophen, pamabrom tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-8103
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SUCROSE (UNII: C151H8M554)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (red and green crystals)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR;7
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-8103-3	50 in 1 BOX	03/01/2021
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	03/01/2021

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)