Premsyn Pms Premenstrual Pain Relief

Premsyn Pms Premenstrual Pain Relief
SPL v8
SPL
SPL Set ID 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49
Route
ORAL
Published
Effective Date 2017-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Bromotheophylline (25 mg) Pyrilamine (15 mg)
Inactive Ingredients
Crospovidone Magnesium Stearate Povidone Stearic Acid Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: purple Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-13

Description

(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





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.

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 enlargment of the prostate gland.

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • 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.

Indications and Usage

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

  • cramps

  • headache

  • bloating

  • backache

  • water-weight gain

  • muscular aches

  • irritability
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

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

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

Pain reliever

Antihistamine

Diuretic

Section 55106-9

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

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.

Ask A Doctor Before Use

you have

  • liver disease

  • glaucoma

  • a breathing problem such as emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland
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 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
If Pregnant Or Breast Feeding,

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. 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 Use

if you are

  • taking the blood thinning drug warfarin 

  • taking sedatives or tranquilizers

Structured Label Content

Indications and Usage (34067-9)

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

  • cramps

  • headache

  • bloating

  • backache

  • water-weight gain

  • muscular aches

  • irritability
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)

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





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.

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 enlargment of the prostate gland.

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • 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.

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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever

Antihistamine

Diuretic

Section 55106-9 (55106-9)

(in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

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.

Ask A Doctor Before Use (Ask a doctor before use)

you have

  • liver disease

  • glaucoma

  • a breathing problem such as emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland
When Using This Product (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 A Doctor If (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
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.)

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 Use (Ask a doctor or pharmacist before use)

if you are

  • taking the blood thinning drug warfarin 

  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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