Label: NOTTS - TENSION HEADACHE- acetaminophen, caffeine tablet
- NDC Code(s): 82706-010-01, 82706-010-02
- Packager: VIVUNT PHARMA LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 24, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver Warning:
Liver warning: This product contains acetaminophen.
Severe 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 ehile using this product.
Allergy alert:
Acetaminophen may cause severe sking reactions. Symptoms may include:
- skin reddening
- rash
- blisters.
If a skin reactions occurs, stop use and seek medical attention immediately
Caffeine warning:
The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness. and occasionally, rapid heartbeat.
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.
- if you are allergic to acetaminophen or any of the inactive ingredients.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- Package Principal Display Panel - TH 24 Caplets
- Package Principal Display Panel - TH 100 Caplets
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INGREDIENTS AND APPEARANCE
NOTTS - TENSION HEADACHE
acetaminophen, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82706-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength TALC (UNII: 7SEV7J4R1U) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POVIDONE (UNII: FZ989GH94E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU) Product Characteristics Color red Score no score Shape OVAL Size 18mm Flavor Imprint Code Notts;TH Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82706-010-01 1 in 1 CARTON 10/30/2023 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:82706-010-02 1 in 1 CARTON 10/30/2023 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 10/30/2023 Labeler - VIVUNT PHARMA LLC (045829437)