perrigo pain relief tablets drug facts

perrigo pain relief tablets drug facts
SPL v1
SPL
SPL Set ID c226205d-7c3c-49af-b3e2-fc7b09ad7857
Route
oral
Published
Effective Date 2011-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg)
Inactive Ingredients
croscarmellose sodium povidone, unspecified stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: 325MG;L403 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 1989-08-15

Purpose

Pain reliever/fever reducer

How Supplied

Acetaminophen 325 mg: color white, shape round (beveled edge) and the imprint code 325MG;L403. NDC: 71335-2574-1: 20 Tablets in a BOTTLE NDC: 71335-2574-2: 100 Tablets in a BOTTLE NDC: 71335-2574-3: 30 Tablets in a BOTTLE NDC: 71335-2574-4: 2 Tablets in a BOTTLE NDC: 71335-2574-5: 6 Tablets in a BOTTLE NDC: 71335-2574-6: 10 Tablets in a BOTTLE NDC: 71335-2574-7: 60 Tablets in a BOTTLE NDC: 71335-2574-8: 90 Tablets in a BOTTLE NDC: 71335-2574-9: 40 Tablets in a BOTTLE NDC: 71335-2574-0: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Description

Acetaminophen 325 mg


Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.

Active Ingredient

Acetaminophen 325 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • minor pain of arthritis
  • backache
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children

6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  • doctor

children under

6 years

ask a doctor

Inactive Ingredients

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

How Supplied

Acetaminophen 325 mg: color white, shape round (beveled edge) and the imprint code 325MG;L403.

NDC: 71335-2574-1: 20 Tablets in a BOTTLE

NDC: 71335-2574-2: 100 Tablets in a BOTTLE

NDC: 71335-2574-3: 30 Tablets in a BOTTLE

NDC: 71335-2574-4: 2 Tablets in a BOTTLE

NDC: 71335-2574-5: 6 Tablets in a BOTTLE

NDC: 71335-2574-6: 10 Tablets in a BOTTLE

NDC: 71335-2574-7: 60 Tablets in a BOTTLE

NDC: 71335-2574-8: 90 Tablets in a BOTTLE

NDC: 71335-2574-9: 40 Tablets in a BOTTLE

NDC: 71335-2574-0: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Acetaminophen 325 mg

Section 51945-4

Acetaminophen 325 mg Tablet

Do Not Use
  • 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 the user has ever had an allergic reaction to this product or any of its ingredients
Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If
  • new symptoms occur
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If the User
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin


Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

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.

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 325 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • minor pain of arthritis
  • backache
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children

6-11 years

  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a
  • doctor

children under

6 years

ask a doctor

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid *may contain this ingredient

How Supplied (HOW SUPPLIED)

Acetaminophen 325 mg: color white, shape round (beveled edge) and the imprint code 325MG;L403.

NDC: 71335-2574-1: 20 Tablets in a BOTTLE

NDC: 71335-2574-2: 100 Tablets in a BOTTLE

NDC: 71335-2574-3: 30 Tablets in a BOTTLE

NDC: 71335-2574-4: 2 Tablets in a BOTTLE

NDC: 71335-2574-5: 6 Tablets in a BOTTLE

NDC: 71335-2574-6: 10 Tablets in a BOTTLE

NDC: 71335-2574-7: 60 Tablets in a BOTTLE

NDC: 71335-2574-8: 90 Tablets in a BOTTLE

NDC: 71335-2574-9: 40 Tablets in a BOTTLE

NDC: 71335-2574-0: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Section 51945-4 (51945-4)

Acetaminophen 325 mg Tablet

Do Not Use (Do not use)
  • 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 the user has ever had an allergic reaction to this product or any of its ingredients
Questions Or Comments? (Questions or comments?)

1-800-719-9260

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If the User (Ask a doctor before use if the user)
  • has liver disease
  • is a child with pain of arthritis
Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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