Pamprin Multisymptom

Pamprin Multisymptom
SPL v4
SPL
SPL Set ID 60b3286d-5698-df50-e053-2991aa0afbe2
Route
ORAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrilamine (15 mg) Bromotheophylline (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Ethylparaben Propylparaben Magnesium Stearate Microcrystalline Cellulose Polyvinyl Alcohol, Unspecified Fd&c Red No. 40 Polyethylene Glycol, Unspecified Fd&c Blue No. 2 Candelilla Wax Starch, Corn Povidone, Unspecified Stearic Acid Talc Sodium Starch Glycolate Type A Potato Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: capsule Color: purple Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-01

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg


Medication Information

Warnings and Precautions

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



Indications and Usage

Uses for the temporary relief of these symptoms associated with menstrual periods:

• cramps

• headache

• bloating

• backache

• water-weight gain

• muscular aches

• irritability

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Pamabrom 25 mg Pyrilamine maleate 15 mg

Section 34088-5

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.

Section 42229-5

IF IMPRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.

Easy-open bottle with child-resisitant packaging. Purchase only if carton end flaps are sealed.

Distributed by:

Focus Consumer Healthcare, LLC

801 Broad Street, Chattanooga, TN 37402

Made in Canada

©2017 Focus Consumer Healthcare, LLC

www.pamprin.com

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a 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

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland

Section 50570-1

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.

Section 51727-6

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4

Maximum Strength

Pamprin Multi-Symptom

for complete Relief of • Cramps •Headache •Backache •Irritability •Bloating

Mentrual Pain Relief

Aspirin-free and Caffeine-free with Acetaminophen, Pamabrom and Pyrilamine Maleate

20 Caplets

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purposes

Pain reliever

Diuretic

Antihistamine

Directions

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

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Questions Or Comments?

Structured Label Content

Indications and Usage (34067-9)

Uses for the temporary relief of these symptoms associated with menstrual periods:

• cramps

• headache

• bloating

• backache

• water-weight gain

• muscular aches

• irritability

Warnings and Precautions (34071-1)

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



Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

IF IMPRINTED INNER SEAL ON BOTTLE IS BROKEN OR MISSING, DO NOT USE.

Easy-open bottle with child-resisitant packaging. Purchase only if carton end flaps are sealed.

Distributed by:

Focus Consumer Healthcare, LLC

801 Broad Street, Chattanooga, TN 37402

Made in Canada

©2017 Focus Consumer Healthcare, LLC

www.pamprin.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a 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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide

Section 51945-4 (51945-4)

Maximum Strength

Pamprin Multi-Symptom

for complete Relief of • Cramps •Headache •Backache •Irritability •Bloating

Mentrual Pain Relief

Aspirin-free and Caffeine-free with Acetaminophen, Pamabrom and Pyrilamine Maleate

20 Caplets

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purposes

Pain reliever

Diuretic

Antihistamine

Directions

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

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

Questions Or Comments? (Questions or Comments?)

Advanced Ingredient Data


Raw Label Data

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