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Cold Max
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride · Cold Max is an over-the-counter drug containing acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride, made by 5 manufacturers.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 5
temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing05/06/2026Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03Wells Pharma of Houston LLC · cGMP deviations.
- Class IIDrugOngoing01/14/2026Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster...SpecGx, LLC · 2 products · Failed Tablet/Capsule Specification: There is a potential for the...
- Class IIDrugOngoing12/17/2025Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL...Fagron Compounding Services · Incorrect Product Formulation
- Class IIDrugOngoing12/10/2025Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave...Park Avenue Compounding · CGMP Deviations
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
Active ingredients
(in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Purpose
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Uses
Temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever
Directions
Do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Warnings
Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours 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. 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 a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). 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, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage 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 lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts 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 In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not use
With any other drug containing acetaminophen (prescription or nonprescription). 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, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use
Liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use
Taking the blood thinning drug warfarin
When using this product
Do not exceed recommended dosage
Stop use and ask a doctor
Nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.
Pregnancy or breastfeeding
Ask a health professional before use.
Keep out of reach of children
Keep out of reach of children.
Other information
Store between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings
Inactive ingredients
Acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Forms and strengths
From the FDA NDC Directory · 5 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet, coated | 5 mg / 325 mg / 10 mg | oral | 1 |
| Tablet, coated | 325 mg / 10 mg / 5 mg | oral | 4 |
What pharmacies pay
National Average Drug Acquisition Cost (NADAC), week of 10/28/2026
Pharmacies paid about $0.0934 per tablet, capsule or unit across 1 package code.
NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.
Manufacturers and labels
5 FDA labels
- TOPCO ASSOCIATES LLCShown hereM012 · Label 12/03/2024 · NDC 36800-521Full label
- AmeriSource BergenM012 · Label 10/18/2024 · NDC 46122-410Full label
- DISCOUNT DRUG MARTM012 · Label 10/17/2024 · NDC 53943-138Full label
- Harris TeeterM012 · Label 10/22/2024 · NDC 72036-138Full label
- MARC GLASSMAN, INC.M012 · Label 10/23/2024 · NDC 68998-238Full label
Cold Max: common questions
- What is Cold Max used for?
- temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever
- Is Cold Max a prescription drug?
- No. Cold Max is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Cold Max?
- Yes. Other FDA-listed products with the same active ingredients include Daytime Cold and Flu, Cold and Flu, Daytime Cold and Flu, Cold Multi-Symptom.
- Who makes Cold Max?
- 5 manufacturers list Cold Max with the FDA, including TOPCO ASSOCIATES LLC, AmeriSource Bergen, DISCOUNT DRUG MART.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/03/2024 · Label text is shown as published by the manufacturer. Not medical advice