Label: EXCEDRIN PM TRIPLE ACTION CAPLETS (acetaminophen, aspirin- nsaid and diphenhydramine citrate tablet, coated
- NDC Code(s): 0067-2056-24, 0067-2056-91
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 14, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 2 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use
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- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
Ask a doctor before use if
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- you have liver disease
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- stomach bleeding warning applies to you
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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- you are taking a diuretic
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- you have asthma
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- you have glaucoma
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- you have a breathing problem such as emphysema or chronic bronchitis
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- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking
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- a prescription drug for:
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- diabetes
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- gout
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- arthritis
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- any other drug, or are under a doctor’s care for any serious condition
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- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
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- sedatives or tranquilizers
When using this product
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- drowsiness will occur
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- avoid alcoholic drinks
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- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
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- an allergic reaction occurs. Seek medical help right away.
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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- pain gets worse or last for more than 10 days
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- painful area is red or swollen
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- ringing in the ears or a loss of hearing occurs
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- any new symptoms occur
These could be signs of a serious condition
- Directions
- Other information
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Inactive ingredients
benzoic acid, calcium carbonate, FD&C blue no. 1 aluminum lake, ferric oxide yellow, hypromellose, low substituted hydroxypropyl cellulose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, zinc stearate
- Questions or comments?
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Principal Display Panel
EXCEDRIN
PM HEADACHE
Acetaminophen 250 mg, Aspirin 250 mg (NSAID)
and Diphenhydramine Citrate 38 mg
Pain Reliever/Nighttime Sleep-Aid
Caffeine-Free
Non-Habit Forming
ACTUAL SIZE
24 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201994
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INGREDIENTS AND APPEARANCE
EXCEDRIN PM TRIPLE ACTION CAPLETS
acetaminophen, aspirin (nsaid) and diphenhydramine citrate tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2056 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 BENZOIC ACID (UNII: 8SKN0B0MIM) CALCIUM CARBONATE (UNII: H0G9379FGK) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ZINC STEARATE (UNII: H92E6QA4FV) Product Characteristics Color BLUE (light blue) Score no score Shape RECTANGLE (oblong shaped tablet) Size 17mm Flavor Imprint Code EXPM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2056-24 1 in 1 CARTON 09/24/2014 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0067-2056-91 1 in 1 CARTON 09/24/2014 2 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/24/2014 Labeler - Haleon US Holdings LLC (079944263)
