Label: PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated
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- NDC Code(s): 70518-0852-0, 70518-0852-1, 70518-0852-2
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 0904-5135
- 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.
Drug Label Information
Updated May 14, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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:
- shock
- facial swelling
- hives
- asthma (wheezing)
Allergy alert: 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
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
- 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
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- 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 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 a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to this product or any of its ingredients
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
- 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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- shock
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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HOW SUPPLIED
Pain Reliever Plus 250mg/250mg/65mg Tablet
NDC: 70518-0852-00 30 in 1 BOTTLE PLASTIC
NDC: 70518-0852-01 24 in 1 BOTTLE PLASTIC
NDC: 70518-0852-02 1 in 1 CARTON, 100 in 1 BOTTLE PLASTIC
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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PRINCIPAL DISPLAY PANEL
DRUG: Pain Reliever Plus
GENERIC: Acetaminophen, Aspirin and caffeine
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0852-0
NDC: 70518-0852-1
NDC: 70518-0852-2
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 11 mm
IMPRINT: 44;159
PACKAGING: 30 in 1 BOTTLE, PLASTIC
PACKAGING: 24 in 1 BOTTLE PLASTIC
PACKAGING 1 in 1 CARTON, 100 in 1 BOTTLE PLASTIC
ACTIVE INGREDIENT(S):
- CAFFEINE 65mg in 1
- ASPIRIN 250mg in 1
- ACETAMINOPHEN 250mg in 1
INACTIVE INGREDIENT(S):
- CROSPOVIDONE
- HYPROMELLOSE, UNSPECIFIED
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- TITANIUM DIOXIDE
- STARCH, CORN
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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:70518-0852(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: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (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) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;159 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70518-0852-0 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2017 05/14/2020 2 NDC:70518-0852-1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/15/2018 3 NDC:70518-0852-2 1 in 1 CARTON 05/12/2020 3 100 in 1 BOTTLE, PLASTIC; 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 11/16/2017 Labeler - REMEDYREPACK INC. (829572556)