NDC | 35418-560-02, 35418-560-67, 35418-560-68, 35418-560-70 |
Set ID | d2d2c37e-5550-4dfc-9551-45164c06b92d |
Category | HUMAN OTC DRUG LABEL |
Packager | Zee Medical Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
WARNINGS
Warnings
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:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Liver warning: 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 a
nonsteroidal 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 (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 beverages while taking
this product because too much caffeine may cause nervousness,
irritability, sleeplessness, and, occasionally, rapid heart beat.
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 nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.
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
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present in the painful area
■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN AID ESF
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-560 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) STARCH, CORN (UNII: O8232NY3SJ) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POVIDONE K29/32 (UNII: 390RMW2PEQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (snow white) Score no score Shape ROUND (ZEE;ESF) Size 12mm Flavor Imprint Code ZEE;ESF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-560-68 50 in 1 CARTON 06/12/2012 1 NDC:35418-560-67 125 in 1 CARTON 1 NDC:35418-560-70 12 in 1 CARTON 1 NDC:35418-560-02 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 06/12/2012 Labeler - Zee Medical Inc (009645623) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultratab Laboratories, Inc. 151051757 manufacture(35418-560) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 repack(35418-560)