Label: URICALM INTENSIVE- acetaminophen, aspirin, caffeine tablet, film coated
- NDC Code(s): 52389-642-01, 52389-642-28
- 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.
Updated September 26, 2013
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- Active ingredients (in each caplet)
Acetaminophen, 250 mg
Aspirin (NSAID)*, 250 mg
Caffeine Anhydrous, 65 mgClose
*Non-steroidal anti-inflammatory drug
Analgesic (pain reliever)
Analgesic (pain reliever)
Pain Reliever AidClose
- INDICATIONS & USAGE
Uses For the temporary relief of minor aches and pains including pain and burning during urination due to urinary tract infections.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:
- facial swelling
- asthma (wheezing)
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.
- ASK DOCTOR
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver disease, liver cirrhosis or kidney disease
- you are taking a diuretic
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- taking any other drug.
- STOP USE
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- pain gets worse or lasts more than 2 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present.
- ringing in the ears or hearing loss occurs.
- you experience fever, chills, back pain or bloody urine
- any 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
If pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed by a doctor because it may cause problems in the unborn child or complications during delivery.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.Close
- 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.
- Other information
**Contents sealed: Each Uricalm Intensive 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.Close
- INACTIVE INGREDIENT
Inactive ingredients: Hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide and triglycerides.Close
- INGREDIENTS AND APPEARANCE
acetaminophen, aspirin, caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-642 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 (UNII: FZ989GH94E) 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:52389-642-28 1 in 1 CARTON 1 NDC:52389-642-01 28 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/23/2013 Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)