Label: THRULIFE EXTRA STRENGTH HEADACHE RELIEF - acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 52605-014-01
- Packager: Polygen Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated December 12, 2012
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- Active ingredient(s)
(in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Pain reliever aid
temporarily relieves minor headaches and pains due to: ●headache ● muscular aches ● premenstrual & menstrual cramps ● cold● sinusitis ● arthritis ● toothache Close
Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox or flu like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives · facial swelling ·asthma (wheezing) · shock
Liver Warning: This product contains acetaminophen.
Severe liver damage may occur if you take · more than 8 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you ·are age 60 or older ·have had stomach ulcers or bleeding problems · take a blood thinning (anticoagulant) or steroid drug ·take other drugs containing prescription or nonprescription NSAIDs ( aspirin, ibuprofen, naproxen, or others) ·have 3 or more alcoholic drinks every day while using this product ·take more or for a longer time than directed.
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.Close
- Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer ·with any other drug containing acetaminophen (prescription or nonprescription).If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Ask a doctor before use if
·you have liver disease ·stomach bleeding warning applies to you ·you have a history of stomach problems, such as heart burn ·you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ·you are taking a diuretic ·you have asthma Close
- Ask a doctor or pharmacist before use if
- a prescription drug fordiabetes, gout, arthritis
- any other drug containing an NSAID (prescription or nonprescription) · a blood thinning (anticoagulant) or steroid drug ·any other drug, or are under a doctor’s care for any serious condition.
- Stop use and ask doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
· feel faint · vomit blood · have bloody or black stools ·have stomach pain that does not get better.
- painful area is red or swollen
- any few symptoms appear ·ringing in the ears or loss of hearing occurs.
●pain gets worse or lasts for more than 10 days ● fever gets worse or lasts for more than 3 daysClose
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a
doctor because it may cause problems in the unborn child or complications during delivery.Close
- Keep out of reach of children
In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Close
- do not use more than directed ·drink a full glass of water with each dose ·adults and children 12 years and over: take 2 caplets every 6 hours: not more than 8 caplets in 24 hours ·
- children under 12 years of age: ask a doctor.
- Other information
- store at controlled room temperature 20º-25ºC (68º-77ºF)
- read all product information before using.
- use by expiration date on package
- Inactive ingredients
Microcrystalline cellulose, Croscarmellose sodium, Stearic acid, Hypromellose, Traicetin, Titanium dioxide & Talc Close
- Dosage & Administration section
- Adults and children 12 years and over: Take 2 caplets every 6 hours; not more than 8 caplets in 24 hours.
- Children under 12 years: ask a doctor
- OTC - Questions section
- Principal Display Panel
Bottle label PDP
EXTRA STRENGTH HEADACHE RELIEF
Carton label PDP
EXTRA STRENGTH HEADACHE RELIEF
- INGREDIENTS AND APPEARANCE
THRULIFE EXTRA STRENGTH HEADACHE RELIEF
acetaminophen, aspirin, caffeine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code P14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52605-014-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 01/31/2013 Labeler - Polygen Pharmaceuticals LLC (962415720) Establishment Name Address ID/FEI Business Operations Polygen Pharmaceuticals LLC 962415720 RELABEL(52605-014) , REPACK(52605-014) , MANUFACTURE(52605-014) , PACK(52605-014)