Label: ADVANCED PAIN RELIEVER- acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 67060-174-67, 67060-174-68
- Packager: ADVANCED FIRST AID, 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 October 1, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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.
Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock
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 with other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
• have 3 or more alcoholic drinks every day while using this product
• you 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 medcations, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use:
• with any other product containing acetaminophen (prescription or nonprescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns
• with any other pain reliever/fever reducer
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
Ask doctor before using if you have:
• stomach problems (such as heartburn, upset stomach or stomach pain)
• stomach bleeding warning applies to you
• gastric ulcers
• bleeding problems
• you have athma, high blood pressure, heart disease, liver disease, or kidney disease
• you are taking a diuretic
Ask a doctor or pharmacist before use if
you are taking a prescription drug for: • anticoagulation (thinning of blood) • diabetes • gout • arthritis
• under a doctor's care for any serious condition
• taking any other drug
When using this product do not exceed recommended dose.
Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.
• an allerginc reaction occurs
Seek medical help right away.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ADVANCED PAIN RELIEVER
acetaminophen, aspirin, caffeine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-174 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (SNOW WHITE) Score no score Shape ROUND Size 11mm Flavor Imprint Code FR9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-174-67 125 in 1 CARTON 08/07/2019 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:67060-174-68 50 in 1 CARTON 08/07/2019 2 2 in 1 PACKET; 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 08/07/2019 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-174) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-174)