Label: PM PAIN RELIEVER- acetaminophen and diphenhydramine citrate tablet
- NDC Code(s): 11822-0373-2
- Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each tablet)
Acetaminophen 500 mgClose
Diphenhydramine citrate 38 mg
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessnessClose
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 other product containin diphenhydramine, even one used on skin
in children under 12 years of age
Ask a doctor before use if you have
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 sedatives or tranquilizers
taking the blood thinning drug warfarin
When using this product
drowsiness may occur
avoid alcoholic beverages
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness lasts 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
fever gets worse or lasts more than 3 days
new symptoms occur
painful area is red or swollen
These could be signs of a serious condition.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 tablets at bedtime. Do not take more than 2 tablets 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.
- Other information
store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
- Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
*Compare to the active ingredients in Excedrin® PM
PM pain reliever
acetaminophen 500 mg
diphenhydramine citrate 38 mg
pain reliever • nighttime sleep aid
100 COATED TABLETS
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Rite Aid 44-373
- INGREDIENTS AND APPEARANCE
PM PAIN RELIEVER
acetaminophen and diphenhydramine citrate tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0373 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 STEARIC ACID TITANIUM DIOXIDE Product Characteristics Color BLUE Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;373 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0373-2 1 in 1 CARTON 1 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part338 06/07/2004 Labeler - Rite Aid (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11822-0373) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11822-0373)