Label: PAIN RELIEF PM- acetaminophen and diphenhydramine citrate tablet, film coated
- NDC Code(s): 21130-373-15
- Packager: Better Living Brands, LLC
- 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.
Updated September 20, 2016
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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 2 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- in children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- liver disease
- 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 (1-800-222-1222) 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 of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor
- children under 12 years: do not use
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- 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
Excedrin® PM Tablets
Pain Relief PM
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE 38 mg
Pain Reliever/Nighttime Sleep-Aid
• Aspirin free
• Non-habit forming
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Excedrin® PM Tablets.
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION
OR YOUR MONEY BACK
Signature Care 44-373
- INGREDIENTS AND APPEARANCE
PAIN RELIEF PM
acetaminophen and diphenhydramine citrate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-373 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:21130-373-15 1 in 1 CARTON 06/07/2004 08/08/2019 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 06/07/2004 08/08/2019 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(21130-373) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(21130-373)