![PAIN RELIEVER PLUS (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]](https://medic.hrt.org//dailymed/images/aa13aecd-0d8a-438d-a83b-af392da48f58/6918951351.jpg)
| NDC | 69189-5135-1 |
| Set ID | aa13aecd-0d8a-438d-a83b-af392da48f58 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Avera McKennan Hospital |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredients (in each tablet)
- Purpose
- Uses
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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
- shock
- asthma (wheezing)
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 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 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, occasionaly, 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 non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
- 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 a prescription drug for diabetes, gout, or arthritis
- taking any other drug or are under a doctor's care for any serious condition
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- painful area is red or swollen
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER PLUS
acetaminophen, aspirin and caffeine tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69189-5135(NDC:0904-5135) 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 CROSPOVIDONE (UNII: 68401960MK) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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 Score no score Shape ROUND Size 13mm Flavor Imprint Code 44;159 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69189-5135-1 1 in 1 DOSE PACK; 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 04/14/2015 Labeler - Avera McKennan Hospital (068647668) Establishment Name Address ID/FEI Business Operations Avera McKennan Hospital 068647668 relabel(69189-5135) , repack(69189-5135)
