Label: BIOELECTRO DAY - acetaminophen, aspirin and caffeine tablet
- NDC Code(s): 62211-285-24
- Packager: A&Z Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENTS
- a cold
- muscular aches
- premenstrual and menstrual cramps
Reye's syndrome: Children and teenagers who have or are recovering for 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
- facial swelling
- asthma (wheezing)
- 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
- more or for a longer time than directed
- 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 beverage while taking this product because too much caffeine may cause nervousness, irritability, sleepleness, and, occasionally, rapid heartbeat.
Do Not Use
- if you 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 drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
- the 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 have asthma
- you are taking a diuretic
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 get worse or lasts for more than 3 days
- any new symptoms appear
Keep Out of Reach of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not use more than directed
- drink a full glass of water in each dose
- adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours
- children under 12 years: ask a doctor
- OTHER INFORMATION
- store at room temperature 20-25°C (68°-77°F)
- Read all product information before using.
- do not use if imprinted safety seal under cap is broken or missing
- You may report serious side effects to 1-888-952-0050
- INACTIVE INGREDIENTS
corn starch, croscarmellose sodium, crospovidone, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide*. *May contain these ingredients.Close
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
acetaminophen and aspirin and caffeine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62211-285 Route of Administration ORAL DEA Schedule 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 STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 18mm Flavor Imprint Code NONE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62211-285-24 24 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/18/2005 Labeler - A&Z Pharmaceutical, Inc. (926820705) Registrant - A&Z Pharmaceutical, Inc. (926820705) Establishment Name Address ID/FEI Business Operations A&Z Pharmaceutical, Inc. 926820705 manufacture(62211-285)