Label: TENSION HEADACHE RELIEF- acetaminophen 500mg tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 71309-105-02, 71309-105-24 - Packager: Safrel Pharmaceuticals, LLC.
- 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 May 31, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Active Ingredients (in each caplet)
- Uses
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Warnings
Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:
- more than 6 tablets 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
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
- Ask a doctor before use
- Ask a doctor or pharmacist
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions or comments?
- Tension Headache Relief Acetaminophen 500mg Caffeine 65mg Compare to Excedrin® Tension Headache active ingredients Distributed by: Safrel Pharmaceuticals, LLC Bridgewater, NJ 08807 www.safrle.com
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INGREDIENTS AND APPEARANCE
TENSION HEADACHE RELIEF
acetaminophen 500mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71309-105 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color red Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71309-105-02 200 in 1 BOTTLE 03/01/2021 1 NDC:71309-105-24 1 in 1 CARTON 1 24 in 1 BOTTLE; 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 - Safrel Pharmaceuticals, LLC. (080566287)