Label: UNISHIELD CRAMP- acetaminophen, pamabrom tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 49314-8103-3 - Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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 DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
UNISHIELD CRAMP
acetaminophen, pamabrom tablet, film coatedProduct 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)