MIDOL TEEN- midol teen tablet, coated 
Bayer HealthCare 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 Teen

Active ingredients (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Purpose

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

Pamabrom 25 mg……….………………………………………….…..Diuretic

Uses

Uses for the temporary relief of these symptoms associated with menstrual periods:
· cramps · bloating · water-weight gain
· headache · backache · muscle aches

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

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

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

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

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

Keep out of reach of children

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

Other informationstore at room temperature

Inactive ingredients

Inactive ingredients carnauba wax, croscarmellose sodium, D&C red #7 calcium lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments

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

Midol Teen

MIDOL TEEN 
midol teen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8030
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code Midol;TEEN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-8030-243 in 1 CARTON07/01/2003
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/200310/31/2018
Labeler - Bayer HealthCare LLC (112117283)

Revised: 7/2022
 
Bayer HealthCare LLC