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NDC 49314-8103-03 Unishield Cramp 325; 25 mg/1; mg/1 Details
Unishield Cramp 325; 25 mg/1; mg/1
Unishield Cramp is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unishield. The primary component is ACETAMINOPHEN; PAMABROM.
Product Information
| NDC | 49314-8103 |
|---|---|
| Product ID | 49314-8103_da5a27d2-b0ac-68ba-e053-2995a90afa63 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Unishield Cramp |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Pamabrom |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; PAMABROM |
| Labeler Name | Unishield |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 49314-8103-03 (49314810303)
| NDC Package Code | 49314-8103-3 |
|---|---|
| Billing NDC | 49314810303 |
| Package | 50 PACKET in 1 BOX (49314-8103-3) / 2 TABLET, FILM COATED in 1 PACKET |
| Marketing Start Date | 2021-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b9d37cad-9b0c-1ab9-e053-2a95a90a5f1d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 |
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| Labeler - Unishield (790677053) |
| Registrant - Unifirst First Aid Corporation (832947092) |