Label: HEADACHE PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated
- NDC Code(s): 68016-231-00
- Packager: Chain Drug Consortium, 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.
Updated January 1, 2018
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- Active ingredients (in each caplet)
Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.
Aspirin may cause a severe allergic reaction which may include:
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 usng 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 (anticogulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)
take more or for a longer time than directed
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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.
DO NOT USE
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 heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are taking
- any other drug containing an NSAID (prescription or nonprescription)
- a blood thinning (anticoagulant) or steroid drug
- a prescription drug for diabetes, gout, or arthritis
- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a 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
- ringing in the ears or loss of hearing occurs
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- any new symptoms appear
If pregnant or breast-feeding, 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.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose Warning: Taking more than the recommended dose
(overdose) may cause liver damage. 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.
- INACTIVE INGREDIENTS
- Other information
- Package label
INGREDIENTS AND APPEARANCE
HEADACHE PAIN RELIEVER
acetaminophen, aspirin and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-231 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE (CAPSULE SHAPED TABLET) Size 18mm Flavor Imprint Code TCL370 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-231-00 1 in 1 CARTON 07/01/2015 1 100 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 07/01/2015 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Geri-Care Pharmaceutical Corp (611196254) Establishment Name Address ID/FEI Business Operations Geri-Care Pharmaceutical Corp 611196254 repack(68016-231)