Extra Sterength Pain Relief PM
EXTRA STRENGTH PAIN RELIEF PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POVIDONE K30 STARCH, PREGELATINIZED CORN WATER STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE S525
Drug Facts
<content styleCode="bold"> <content styleCode="italics">Active ingredients (in each caplet)</content> </content> Acetaminophen 500 mg Diphenhydramine HCl 25 mg
<content styleCode="italics"> <content styleCode="bold">Purpose</content> </content> Pain reliever Nighttime sleep aid
<content styleCode="italics"> <content styleCode="bold">Uses</content> </content> For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
<content styleCode="bold">Liver warning</content> 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
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.
<content styleCode="bold">Do not use</content> 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
<content styleCode="bold">Ask a doctor before use if you have</content> liver disease breathing problems such as emphysema or chronic bronchitis trouble urinating due to an enlargement of the prostate gland glaucoma
<content styleCode="bold">Ask a doctor or pharmacist before use if you are</content> taking the blood thinning drug warfarin taking sedatives or tranquilizers
<content styleCode="bold">When using this product</content> drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery
<content styleCode="bold">Stop use and ask a doctor if</content> 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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
<content styleCode="bold">Overdose warning</content> 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.
<content styleCode="italics"> <content styleCode="bold">Directions</content> </content> do not take more than directed (see overdose warning)
adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours
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
<content styleCode="italics"> <content styleCode="bold">Other information</content> </content> each caplet contains: magnesium 0.05 mg store between 20°-25°C (68°-77°F)
<content styleCode="italics"> <content styleCode="bold">Inactive ingredients</content> </content> 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
<content styleCode="italics"> <content styleCode="bold">Questions or comments?</content> </content> 1-888-333-9792
PRINCIPAL DISPLAY PANEL Extra Strength
Pain relief PM
Acetaminophen 500 mg - Pain Reliever
Diphenhydramine 25 mg - Nighttime Sleep-Aid Non-habit forming
24 Softgels Carton DP