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  5. Label Information: Panadol PM

FDA Label for Panadol PM

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    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 YOU ARE TAKING
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST-FEEDING,
    12. OVERDOSE WARNING:
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS?
    17. PRINCIPAL DISPLAY PANEL

Panadol PM Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings 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.

Active Ingredients (In Each Caplet)



Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Purposes



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 are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have



  • •liver disease
  • •glaucoma
  • •a breathing problem such as emphysema or chronic bronchitis
  • •trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are Taking



  • •the blood thinning drug warfarin
  • •sedatives or tranquilizers

When Using This Product



  • •drowsiness will occur
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If



  • •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • •pain gets worse or lasts more than 10 days
  • •redness or swelling is present
  • •any new symptoms appear

    • These could be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Overdose Warning:



Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 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)
  • •adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
  • •do not give to children under 12 years of age

Other Information



  • •store at 25°C (77°F)

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, stearic acid, talc, titanium dioxide


Questions?



1-800-455-7139


Principal Display Panel



NDC 0135-7021-01

Panadol

EXTRA STRENGTH

PM

ACETAMNOPHEN

Pain Reliever

DIPHENHYDRAMINE HCl

Nighttime Sleep-Aid

2 CAPLETS

TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN

Fold Back And Tear To Open Or Use Scissors

Distributed by:

GSKConsumer Healthcare, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

TR-0630-765-24 ORG

TR-0630-765-24 Panadol PM 2 ct - image 01

TR-0630-765-24 Panadol PM 2 ct - image 01


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