midol complete gelcaps

midol complete gelcaps
SPL v6
SPL
SPL Set ID 0a4477ce-0a02-197d-e054-00144ff88e88
Route
oral
Published
Effective Date 2014-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
caffeine (60 mg) pyrilamine (15 mg) acetaminophen (500 mg)
Inactive Ingredients
d&c red no. 33 aluminum oxide edetate disodium ferrosoferric oxide carnauba wax croscarmellose sodium fd&c blue no. 1 gelatin glycerin

Identifiers & Packaging

Pill Appearance
Imprint: MIDOL Shape: oval Color: turquoise Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2014-12-15

Description

Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine


Medication Information

Warnings and Precautions

Warnings

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

· more than 6 gelcaps in 24 hours, which is the maximum daily amount

for this product

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

· skin reddening · blisters · rash

· hives · facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient

Active ingredients (in each gelcap) Purpose

Acetaminophen 500 mg..............................………………….Pain reliever

Caffeine 60 mg……….…………………………………….……..….Diuretic

Pyrilamine maleate 15 mg……………………………………Antihistamine

Indications and Usage

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle ache
  • fatigue
Dosage and Administration

Directions

· do not take more than the recommended dose

· adults and children 12 years and older:

· take 2 gelcaps with water

· repeat every 6 hours, as needed

· do not exceed 6 gelcaps per day

· children under 12 years: consult a doctor

Description

Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine

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 50566-9

Stop use and ask a doctor if

· new symptoms occur

· redness or swelling is present

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

Section 50567-7

When using this product

· you may get drowsy

· avoid alcoholic drinks

· excitability may occur, especially in children

· alcohol, sedatives, and tranquilizers may increase drowsiness

· be careful when driving a motor vehicle or operating machinery

· limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

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

· difficulty in urination due to enlargement of the prostate gland

· a breathing problem such as emphysema or chronic bronchitis

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.

· if you have ever had an allergic reaction to this product or any of its

ingredients

Section 51727-6

Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

Section 51945-4

Section 53413-1

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

Section 53414-9

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

Section 60561-8

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

· more than 6 gelcaps in 24 hours, which is the maximum daily amount

for this product

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

· skin reddening · blisters · rash

· hives · facial swelling · asthma (wheezing) · shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient (55106-9)

Active ingredients (in each gelcap) Purpose

Acetaminophen 500 mg..............................………………….Pain reliever

Caffeine 60 mg……….…………………………………….……..….Diuretic

Pyrilamine maleate 15 mg……………………………………Antihistamine

Indications and Usage (34067-9)

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

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle ache
  • fatigue
Dosage and Administration (34068-7)

Directions

· do not take more than the recommended dose

· adults and children 12 years and older:

· take 2 gelcaps with water

· repeat every 6 hours, as needed

· do not exceed 6 gelcaps per day

· children under 12 years: consult a doctor

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 50566-9 (50566-9)

Stop use and ask a doctor if

· new symptoms occur

· redness or swelling is present

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

Section 50567-7 (50567-7)

When using this product

· you may get drowsy

· avoid alcoholic drinks

· excitability may occur, especially in children

· alcohol, sedatives, and tranquilizers may increase drowsiness

· be careful when driving a motor vehicle or operating machinery

· limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

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

· difficulty in urination due to enlargement of the prostate gland

· a breathing problem such as emphysema or chronic bronchitis

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.

· if you have ever had an allergic reaction to this product or any of its

ingredients

Section 51727-6 (51727-6)

Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)


Advanced Ingredient Data


Raw Label Data

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