Label: HEADACHE RELIEF PM- acetaminophen, aspirin, and diphenhydramine citrate tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-9894-12 - Packager: Walgreens
- 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 December 13, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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- ACTIVE INGREDIENT
- 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:
- skin reddening
- blisters
- 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:
- hives
- facial swelling
- asthma (wheezing)
- shock
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 2 caplets 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
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 had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
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 or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if
- you have liver disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
- you have glaucoma
- you have a breathing problem such as emphysema or chronic bronchitis
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- diabetes
- gout
- arthritis
- any other drug, or are under a doctor's care for any serious condition
- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
- sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask 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
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or last for more than 10 days
- painful area is red or swollen
- ringing in the ears or a loss of hearing occurs
- 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, colloidal silicon dioxide, hydroxypropyl cellulose, iron oxide yellow, maltodextrin, magnesium stearate, microcrystalline cellulose Type 101, microcrystalline cellulose Type 112, medium chain triglycerides, Opadry Blue, pregelatinized corn starch, polysorbate 80, povidone K30, stearic acid, talc, zinc stearate
- Questions or comments
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PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton
Well at
WalgreensNDC 0363-9894-12
WALGREENS PHARMACIST RECOMMENDED ‡
Headache
Relief PMAcetaminophen / Pain Reliever
Aspirin (NSAID) / Pain Reliever
Diphenhydramine Citrate / Nighttime Sleep Aid- Caffeine free
- Non-habit forming
NIGHTTIME
100 CAPLETS
Compare to Excedrin ® PM Headache Triple
Action Formula Caplets active ingredients ‡‡ -
INGREDIENTS AND APPEARANCE
HEADACHE RELIEF PM
acetaminophen, aspirin, and diphenhydramine citrate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9894 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) ZINC STEARATE (UNII: H92E6QA4FV) Product Characteristics Color blue Score no score Shape OVAL (CAPSULE SHAPED) Size 18mm Flavor Imprint Code S521 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9894-12 1 in 1 CARTON 12/15/2017 1 100 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 02/15/2016 Labeler - Walgreens (008965063) Registrant - Spirit Pharmaceuticals LLC (179621011) Establishment Name Address ID/FEI Business Operations MOLECULES DRUGS & RESEARCH LABORATORY PVT. LTD. 860240133 manufacture(0363-9894)