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.

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 55106-9

Active ingredients (in each gelcap) Purpose

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

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

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

Section 60561-8

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)


Structured Label Content

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

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.

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 55106-9 (55106-9)

Active ingredients (in each gelcap) Purpose

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

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

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

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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