PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet, coated
HyVee Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
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 lasts 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)
adults and children 12 years and over
|
-
take 2 geltabs at bedtime
-
do not take more than 2 geltabs of this product in 24 hours
|
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
See New Warnings
COMPARE TO the Active Ingredients of Extra Strength Tylenol® PM
Pain Relief PM
Pain Reliever / Nighttime Sleep Aid
Acetaminophen / Diphenhydramine HCl
Extra Strength
ACTUAL SIZE
For Adults
Non-Habit forming
50 GELTABS