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  5. Label Information: First Aid Only Extra-strength Non-aspirin

FDA Label for First Aid Only Extra-strength Non-aspirin

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. ALLERGY ALERT:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    9. STOP USING AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. ADULTS AND CHILDREN: (12 YEARS AND OLDER)
    14. CHILDREN UNDER 12 YEARS:
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. OTC - QUESTIONS
    18. FIRST AID ONLY EXTRA-STRENGTH NON-ASPIRIN LABEL

First Aid Only Extra-strength Non-aspirin Product Label

The following document was submitted to the FDA by the labeler of this product Acme United Corporation. 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

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
  • 3 or more alcoholic drinks every day while using this product

Active Ingredient (In Each Tablet)



Acetaminophen 500 mg


Purpose



Pain reliever/fever reducer


Uses



For the temporary relief of minor aches and pains associated with

  • headache
  • toothache
  • minor arthritis pain
  • muscular aches
  • common cold
  • menstrual cramps

    • temporarily reduces fever


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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 Using And Ask A Doctor If



  • symptoms do not improve
  • pain or fever persists or gets worse
  • new symptoms occur
  • redness or swelling is present

Otc - Pregnancy Or Breast Feeding



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


Keep Out Of Reach Of Children.



In case of accidental 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.


Directions



  • do not use more than directed

Adults And Children: (12 Years And Older)



Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.


Children Under 12 Years:



Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may

cause liver damage.


Other Information



  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients



corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

* May contain


Otc - Questions



Questions? 1-800-835-2263


First Aid Only Extra-Strength Non-Aspirin Label



First Aid Only Extra-Strength Non-Aspirin Label

First Aid Only Extra-Strength Non-Aspirin Label - BOX7008 revC

First Aid Only Extra-Strength Non-Aspirin Label - BOX7008 revC


* Please review the disclaimer below.