FDA Label for Extra Strength Pain Relief Pm
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Extra Strength Pain Relief Pm Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals 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.
Other
Drug Facts
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.
Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep aid
Uses
For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Warnings
Liver Warning
This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product
Do Not Use
- with other drug 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
- breathing problems such as emphysema or chronic bronchitis
- trouble urinating due to an enlargement of the 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 a serious underlying medical illness
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts 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.
Overdose Warning
Taking more than the directed 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
- do not take more than directed (see overdose warning)
- take 2 caplets at bedtime
- do not take more than 2 caplets of this product in 24 hours
adults and children 12 years and over | |
children under 12 years | do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
Other Information
- each caplet contains: magnesium 0.05 mg
- store between 20°-25°C (68°-77°F)
Inactive Ingredients
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone k-30, pregelatinized starch, purified water, stearic acid, titanium dioxide
Questions Or Comments?
1-888-333-9792
Principal Display Panel
COMPARE TO ACTIVE INGREDIENTS OF
EXTRA STRENGTH TYLENOL® PM
EXTRA STRENGTH
Pain Relief PM
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Pain Reliever/Nighttime Sleep-Aid
100 caplets
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