Pamprin Max Menstrual Pain Relief

Pamprin Max Menstrual Pain Relief
SPL v9
SPL
SPL Set ID 5bd4b935-f003-7df8-e053-2a91aa0a5d79
Route
ORAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
D&c Red No. 27 Fd&c Red No. 40 Medium-chain Triglycerides Hypromelloses Maltodextrin Cellulose, Microcrystalline Polydextrose Silicon Dioxide Stearic Acid Talc Titanium Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: MAX Shape: oval Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-18

Description

Pain reliever Diuretic *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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

Allergy warning: 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 8 caplets 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 occasionally, rapid heartbeat.

Indications and Usage

For the temporary relief of these symptoms associated with menstrual periods:

  • cramps

  • headache

  • backache

  • fatigue

  • bloating
Dosage and Administration

Adults and children 12 years and over:

• take 2 caplets with water every 6 hours as needed

• do not exceed 8 caplets in a 24 hour period or as directed by a doctor

• do not use more than directed (see warnings)

children under 12 years: ask a doctor

Description

Pain reliever Diuretic *nonsteroidal anti-inflammatory drug

Section 42229-5

When using this product

  • you may get drowsy, avoid alcoholic beverages
  • alcohol sedatives and tranquilizers may increase drowsiness
  • use caution when driving or operating machinery
  • excitability may occur especially in children

stop use and ask doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 51727-6

D&C Red No. 27 Lake, FD&C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)

Section 51945-4

Section 55105-1

Pain reliever

Diuretic

*nonsteroidal anti-inflammatory drug

Section 55106-9

(in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Do Not Use

• if you are allergic to 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.

Ask A Doctor Before Use If
  • you have liver disease

  • the 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 are taking a diuretic
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
  • redness or swelling is present

  • new symptoms occur

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 Or Pharmacist Before

if you are taking a prescription drug for gout, diabetes or arthritis


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of these symptoms associated with menstrual periods:

  • cramps

  • headache

  • backache

  • fatigue

  • bloating
Dosage and Administration (34068-7)

Adults and children 12 years and over:

• take 2 caplets with water every 6 hours as needed

• do not exceed 8 caplets in a 24 hour period or as directed by a doctor

• do not use more than directed (see warnings)

children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

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

Allergy warning: 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 8 caplets 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 occasionally, rapid heartbeat.

Section 42229-5 (42229-5)

When using this product

  • you may get drowsy, avoid alcoholic beverages
  • alcohol sedatives and tranquilizers may increase drowsiness
  • use caution when driving or operating machinery
  • excitability may occur especially in children

stop use and ask doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

D&C Red No. 27 Lake, FD&C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever

Diuretic

*nonsteroidal anti-inflammatory drug

Section 55106-9 (55106-9)

(in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Do Not Use (Do not use)

• if you are allergic to 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.

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have liver disease

  • the 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 are taking a diuretic
Stop Use and Ask A Doctor If (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
  • redness or swelling is present

  • new symptoms occur

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • ringing in the ears or loss of hearing occurs
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

In case of overdose, get medical help or contact a Poison Control Center right away. 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 Or Pharmacist Before (Ask a doctor or pharmacist before)

if you are taking a prescription drug for gout, diabetes or arthritis


Advanced Ingredient Data


Raw Label Data

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