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  5. Label Information: Pm Get Relief

FDA Label for Pm Get Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING
    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. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL - 50 POUCH CARTON

Pm Get Relief Product Label

The following document was submitted to the FDA by the labeler of this product Eagle Distributors,inc.. 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

Product manufactured for:
Eagle Distributors,Inc.
Los Angeles, CA 90011


Otc - Purpose



Active ingredients (in each caplet)Purposes
Acetaminophen 500 mgPain reliever
Diphenhydramine HCl 25 mgNighttime sleep aid

Uses



temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness


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

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 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.


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



Taking more than the recommended dose (overdose) may cause liver damage. 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



Adults and children 12 years of age and overTake 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years of ageDo not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems

Other Information



  • store between20-25 C (68-77 F)
  • do not use if pouch is torn or open

Inactive Ingredients



croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.


Questions Or Comments?



Call 1-800-570-8650 (M-F 9am to 5pm PST)


Principal Display Panel - 50 Pouch Carton



See New Warnings Information & Directions
Compare to the Active Ingredients in
Tylenol PM®*

Extra Strength
PM
Get Relief
Pain Reliever
Nighttime Sleep Air

Acetaminophen, Diphenhydramine HCI

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton - pm get relief 01

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton - pm get relief 01


* Please review the disclaimer below.