MIDOL- acetaminophen, caffeine, and pyrilamine maleate tablet 
Savings Distributors LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Midol

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpose

Pain reliever

Diuretic

Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:
● cramps ●bloating ●water-weight gain ●headache

●backache ●muscle aches ●fatigue

Warnings

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

● 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

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.

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.

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

Other information

store at room temperature

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

Questions?

1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.com

Package Label

Package Label

MIDOL 
acetaminophen, caffeine, and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-007(NDC:0280-8005)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL ((oblong)) Size17mm
FlavorImprint Code MIDOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73097-007-021 in 1 CARTON07/05/2019
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:73097-007-4020 in 1 CARTON07/05/2019
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:73097-007-5025 in 1 CARTON07/05/2019
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/05/2019
Labeler - Savings Distributors LLC (010527359)

Revised: 7/2019
Document Id: 8d6ed3ad-fd3f-47f3-e053-2995a90aba28
Set id: 8d6edcac-504b-d437-e053-2995a90a6b7a
Version: 1
Effective Time: 20190711
 
Savings Distributors LLC