Label: HEADACHE RELIEF PM- acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
- NDC Code(s): 55910-674-15
- Packager: DOLGENCORP, 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 July 16, 2019
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- Active ingredients (in each caplet)
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
- facial swelling
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- are age 60 or older
- have 3 or more alcoholic drinks every day while using this product
- have had stomach ulcers or bleeding problems
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
Do not use
- if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor 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
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have glaucoma
- you have asthma
- you have difficulty in urination due to enlargement of the prostate gland
- you are taking a diuretic
- you have a breathing problem such as emphysema or chronic bronchitis
- you have liver disease
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask a doctor or pharmacist before use if you are
- a prescription drug for:
- any other drug, or are under a doctor’s care for any serious condition
- sedatives or tranquilizers
- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
When using this product
- avoid alcoholic beverages
- drowsiness may occur
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- 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
- 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. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
Compare to active
ingredients of Excedrin®
Headache Relief PM
Pain Reliever/Nighttime Sleep Aid
• Caffeine free • Non-habit forming
Actual Caplet Size
**This product is not manufactured or distributed by Novartis AG,
owner of the registered trademark Excedrin® PM Headache.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DG Health 44-674
INGREDIENTS AND APPEARANCE
HEADACHE RELIEF PM
acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-674 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POVIDONE (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SODIUM SULFATE (UNII: 0YPR65R21J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ZINC STEARATE (UNII: H92E6QA4FV) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color BLUE Score no score Shape OVAL Size 17mm Flavor Imprint Code 674 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-674-15 1 in 1 CARTON 08/31/2016 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 08/31/2016 Labeler - DOLGENCORP, LLC (068331990) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(55910-674) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(55910-674) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(55910-674) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(55910-674)