1. Home
  2. Labeler Index
  3. American Sales Company
  4. 41520-208
  5. Label Information: Careone Acetaminophen Pm

FDA Label for Careone Acetaminophen Pm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GELTAB)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Careone Acetaminophen Pm Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. 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.

Active Ingredients (In Each Geltab)



Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Purpose



Pain reliever

Nighttime sleep-aid


Uses



temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness


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 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • •with any other product containing diphenhydramine, even one used on skin
  • •in children under 12 years of age
  • •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
  • •trouble urinating due to an enlarged prostate gland
  • •glaucoma

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
  • •redness or swelling is present
  • •new symptoms occur

    • These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


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



  • •do not take more than directed (see overdose warning)
    • take 2 geltabs at bedtime
  • do not take more than 2 geltabs of this product in 24 hours

    adults and children 12 years and over

    ••

    children under 12 years

    do not use


Inactive Ingredients



crospovidone, D&C red #33 aluminum lake, edetate disodium, edible ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredients in Tylenol® PM

Extra Strength

ACETAMINOPHEN PM

Acetaminophen, 500mg

Diphenhydramine HCl, 25mg

Pain Reliever/Nighttime Sleep-Aid

For Adults

Non-habit forming

Gluten Free

OUR PHARMACISTS RECOMMEND

Actual Size

50 GELTABS


* Please review the disclaimer below.