Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Generic name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
Manufacturer
OPMX LLC
Product type
HUMAN OTC DRUG
SPL set ID
b373a3a8-68c4-0187-e053-2995a90aad62
SPL ID
2860515b-46f8-6018-e063-6294a90af085
Version
4
Effective date
2024-12-03
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:16
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI if you have ever had an allergic reaction to this product or any of its ingredients. to make a child sleepy Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor ot pharmacist if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcohol drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or last more than 3 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. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.