Cold Medicine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

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

Brand name
Cold Medicine
Generic name
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL
Manufacturer
Selder, S.A. de C.V.
Product type
HUMAN OTC DRUG
SPL set ID
d2762d9c-e7e7-42b2-a26a-14b2aa0307cb
SPL ID
f7300376-dd92-4f5e-b68d-175e8023ca44
Version
5
Effective date
2017-01-25
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:52
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 12 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. 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. Do not use ■ if you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ 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, ask a doctor or pharmacist before taking this product ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have ■ liver disease ■ heart disease ■ glaucoma ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you ■ are taking the blood thinning drug warfarin ■ are taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ redness or swelling is present ■ new symptoms occur ■ you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days If pregnant or breast-feeding, If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Keep out of reach of children. In case of overdose, contact a Poison Control Center (1-800-222-1222) immediately. 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.