FDA Label for Midol Long Lasting Relief
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Midol Long Lasting Relief Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each caplet)
Acetaminophen 650 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Uses
Uses
- Temporarily relieves minor aches and pains due
- muscular aches
- backache
- minor pain of athritis
- toothache
- premenstrual and mentrual cramps
- headache
- the common cold
- temporarily reduces fever
Warnings
Warnings
Liver warning: The product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
- If a skin reaction occurs, stop use and seek medical help right away.
Allergy Alert: Acetaminophen may cuse severe skin reactions.
Symptoms may include:
Otc - 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 are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
- If you are allergic to acetaminophen or any of the inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Otc - Stop Use
Stop use and ask a doctor if
- 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
These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 directed (see overdose warning)
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
- do not use
adults and children 12 years and over | |
children under 12 years |
Other Information
Other information
- store at 20-25° (68-77°F). Avoid excessive heat 40°C (104°F).
- do not use if printedfoil under cap is broken or missing
Inactive Ingredient
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
Questions Or Comments
Questions or comments? 1-800-331-4536
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