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Midol PM

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: Bayer HealthCare LLC
NDC Code: 0280-8070

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.

Midol PM

Drug Facts

Active ingredients (in each caplet) Purpose

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

Diphenhydramine citrate 38 mg…….…………………..Nighttime sleep-aid

Use for relief of occasional sleeplessness when associated with minor aches and pains from premenstrual and menstrual periods (dysmenorrhea).

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

· more than 4,000 mg of acetaminophen in 24 hours

· 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.

· in children under 12 years of age

· with any other product containing diphenhydramine, even one used

on skin

· 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

· a breathing problem such as emphysema or chronic bronchitis

· glaucoma

· difficulty in urination due to enlargement 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

· drowsiness will occur

· avoid alcoholic drinks

· do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

· sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts 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.

Directions

Directions

· do not take more than the recommended dose

· adults and children 12 years and older: take 2 caplets at bedtime if needed, or as directed by a doctor

· children under 12 years: do not use

Other information store at room temperature

Inactive ingredients

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, povidone, propylene glycol, shellac, stearic acid, titanium dioxide

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

MIDOL PM 
midol pm tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8070
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
PROPYLENE GLYCOL 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
SHELLAC 
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
ALUMINUM OXIDE 
FD&C BLUE NO. 2 
HYPROMELLOSES 
Product Characteristics
ColorblueScoreno score
ShapeOVALSize7mm
FlavorImprint CodeMIDOL;PM
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-8070-201 BOTTLE, PLASTIC in 1 CARTON
120 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/15/2014
Labeler - Bayer HealthCare LLC (785159372)
Establishment
NameAddressID/FEIOperations
Bayer HealthCare LLC Consumer Care072827066manufacture(0280-8070), pack(0280-8070)

 
Bayer HealthCare LLC

Medically reviewed on Dec 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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