Label: ARTHRITEN INFLAMMATORY PAIN FORMULA- acetaminophen, aspirin, caffeine tablet, film coated
- NDC Code(s): 52389-237-01, 52389-237-28
- Packager: Alva-Amco Pharmacal Companies, Inc.
- 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 October 25, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- INDICATIONS & USAGE
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.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours, which is the maximum daily amount for this product.
- with other products containing acetaminophen
- 3 or more alcoholic drinks every day while using this product.
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (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 (anti-coagulant) 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.
DO NOT USE
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or non-prescription). 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.
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- symptoms do not improve
- pain or fever persists or gets worse
- redness or swelling is present.
- ringing in the ears or hearing loss occurs.
- new symptoms occur
- you experience any of the following signs of stomach bleeding:
- you feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Read all package directions and warnings before use and use only as directed.
- Adults: Two (2) caplets every 6 hours while symptoms persist, not to exceed 4 doses (8 caplets) in 24 hours, or as directed by a doctor.
- Drink a full glass of water with each dose
- Intended for use by normally healthy adults only
- Persons under 18 years of age should use only as directed by a doctor.
**Contents sealed: Each Arthriten white colored, capsule shaped caplet bears the identifying mark "ALVA" and a "2" on the reverse side, and is packaged in a bottle with a safety seal under the cap. Do not use if the seal appears broken or if product contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ARTHRITEN INFLAMMATORY PAIN FORMULA
acetaminophen, aspirin, caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-237 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color white Score no score Shape CAPSULE (capsule-shaped caplet) Size 17mm Flavor Imprint Code ALVA;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52389-237-28 1 in 1 CARTON 07/23/2012 1 NDC:52389-237-01 28 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 not final part343 07/23/2012 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)