NDC 49314-8103 Unishield Cramp

Acetaminophen, Pamabrom

NDC Product Code 49314-8103

NDC CODE: 49314-8103

Proprietary Name: Unishield Cramp What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Pamabrom What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Shape: ROUND (C48348)
11 MM
Score: 1

NDC Code Structure

  • 49314 - Unishield

NDC 49314-8103-3

Package Description: 50 PACKET in 1 BOX > 2 TABLET, FILM COATED in 1 PACKET

NDC Product Information

Unishield Cramp with NDC 49314-8103 is a a human over the counter drug product labeled by Unishield. The generic name of Unishield Cramp is acetaminophen, pamabrom. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Unishield

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Unishield Cramp Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 325 mg/1
  • PAMABROM 25 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Unishield
Labeler Code: 49314
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Unishield Cramp Product Label Images

Unishield Cramp Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet) Acetaminophen 325 mgPamabrom 25 mg

Otc - Purpose

PurposePain reliever/fever reducerDiuretic

Indications & Usage

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


WarningsLiver 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 productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening■ blisters■ rashIf a skin reaction occurs, stop use and seek medical help right away.

Otc - 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

Otc - Ask Doctor

Ask a doctor before use if you have■ liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if■ you are taking the blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose.

Otc - 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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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 tabletsAdults 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 ingredientsD&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose,povidone, starch, stearic acid, sucrose

Otc - Questions

Questions or comments? 800-480-5856

Unishield Cramp Tabs

UnishieldCramp TabsMenstrual Relief100 Tablets/ 1 Tablet Per PacketAcetaminophen 325 mgPamabrom 25 mgPull To OpenThis Package is for Households without Young Children.• Reduces water-weight gain• Relieves headaches, backaches and muscular aches & painsRelieves Cramps and BloatingTamper Evident Unit Dose Packets

* Please review the disclaimer below.