Label: EXTRA STRENGTH PAIN RELIEF PM- acetaminophen 500mg diphenhydramine hcl 25mg tablet, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 53943-024-01, 53943-024-03, 53943-024-50 - Packager: Discount Drug Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 18, 2013
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
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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 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
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
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STOP USE AND ASK DOCTOR IF
- Sleeplessness persists 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.
- PREGNANCY/BREASTFEEDING
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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. (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.
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DIRECTIONS
- 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
- STORAGE
- INACTIVE INGREDIENT SECTION
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PRINCIPAL DISPLAY PANEL
Carton Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
50 COATED CAPLETS
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
50 COATED CAPLETS
CARTON LABEL PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
100 COATED CAPLETS
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
100 COATED CAPLETS
Bottle Label PDP
Drug mart
EXTRA STRENGTH
PAIN RELIEF PM
NON-ASPIRIN PAIN RELIEVER/ SLEEP AID
CAPLETS
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
300 COATED CAPLETS
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEF PM
acetaminophen 500mg diphenhydramine hcl 25mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code P24 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-024-50 1 in 1 CARTON 1 50 in 1 BOTTLE 2 NDC:53943-024-01 1 in 1 CARTON 2 100 in 1 BOTTLE 3 NDC:53943-024-03 300 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 06/20/2013 Labeler - Discount Drug Mart (047741335) Registrant - Discount Drug Mart (047741335)