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  5. Label Information: Extra Strength Pain Reliever

FDA Label for Extra Strength Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Mechanical Servants 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.

Otc - Active Ingredient



ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 500 mg


Otc - Purpose



Analgesic, Antipyretic (fever reducer)


Indications & Usage



Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain

Temporarily reduces fever


Warnings



Warnings:

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening

• blisters

• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

When using this product do not exceed recommended dose.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if: • pain or fever persists or gets worse or lasts for more than 10 days • fever gets worse or lasts for 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Dosage & Administration



Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: consult a doctor


Inactive Ingredient



Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

*contains one or more of these ingredients


Package Label.Principal Display Panel




* Please review the disclaimer below.