Midol Complete — v5

Midol Complete

6 Views

Version

v5

Effective date

November 5, 2023

Original packager

Sections captured

17

Identifiers

Document ID
09735b2f-2b04-ca91-e063-6294a90a210a
Set ID
15176109-782e-4208-bb21-2f62da4a6dfa
Application numbers
M013
Product NDCs
50269-007
Package NDCs
50269-007-06
Original packager NDCs
0280-8005

Names & Manufacturers

Brand names
Midol Complete
Generic names
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Manufacturer names
JC World Bell Wholesale Co., Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Routes
ORAL
Pharmacologic class (PE)
Central Nervous System Stimulation [PE]
Pharmacologic class (EPC)
Central Nervous System Stimulant [EPC], Methylxanthine [EPC]
Pharmacologic class (CS)
Xanthines [CS]
Mechanism of action

Other identifiers

NUI
M0023046, N0000175729, N0000175739, N0000175790
RxCUI
1597298
UNII
362O9ITL9D, 3G6A5W338E, R35D29L3ZA
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg Purpose Pain reliever Diuretic Antihistamine
Ask Doctor (1)

Sequence 1

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
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Do Not Use (1)

Sequence 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
Dosage And Administration (1)

Sequence 1

Directions do not take more than the recommended dose adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 6 caplets per day children under 12 years: consult a doctor
Inactive Ingredient (1)

Sequence 1

Inactive ingredients carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
Indications And Usage (1)

Sequence 1

Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle aches fatigue
Keep Out Of Reach Of Children (1)

Sequence 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.
Package Label Principal Display Panel (1)

Sequence 1

Package Labeling: Label2
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Purpose Pain reliever Diuretic Antihistamine
Questions (1)

Sequence 1

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

Sequence 1

Midol Complete ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL SHELLAC TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE PYRILAMINE MALEATE PYRILAMINE oblong MIDOL
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Other information Store at room temperature. Avoid excessive heat above 40°C (104°F).
Stop Use (1)

Sequence 1

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
Warnings (1)

Sequence 1

Warnings This product contains acetaminophen. Severe liver damage may occur if you take Liver warning: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: Allergy alert : more than 6 caplets 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 skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic occurs, stop use and seek medical help right away. 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 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 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 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. 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 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.
When Using (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['M013'],
 'brand_name': ['Midol Complete'],
 'generic_name': ['ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE'],
 'manufacturer_name': ['JC World Bell Wholesale Co., Inc.'],
 'nui': ['N0000175739', 'N0000175729', 'N0000175790', 'M0023046'],
 'original_packager_product_ndc': ['0280-8005'],
 'package_ndc': ['50269-007-06'],
 'pharm_class_cs': ['Xanthines [CS]'],
 'pharm_class_epc': ['Central Nervous System Stimulant [EPC]',
                     'Methylxanthine [EPC]'],
 'pharm_class_pe': ['Central Nervous System Stimulation [PE]'],
 'product_ndc': ['50269-007'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1597298'],
 'spl_id': ['09735b2f-2b04-ca91-e063-6294a90a210a'],
 'spl_set_id': ['15176109-782e-4208-bb21-2f62da4a6dfa'],
 'substance_name': ['ACETAMINOPHEN', 'CAFFEINE', 'PYRILAMINE MALEATE'],
 'unii': ['362O9ITL9D', '3G6A5W338E', 'R35D29L3ZA']}