Maximum strength Max Cold and Sinus
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2024-01-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:07
Label at a glance#
ProductMaximum strength Max Cold and Sinus
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients
(in each 20 mL)
Acetaminophen 650 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
Purpose
Acetaminophen Pain reliever/Fever reducer
Guaifenesin Expectorant
Phenylephrine HCl Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these common cold and flu symptoms:
• nasal congestion
• sinus congestion and pressure
• minor aches and pains
• sore throat
• headache
• fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
WARNINGS SECTION
Warnings
Liver warning
This product contains acetaminophen.
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.
• for children under 12 years of age
Ask a doctor before use if you have
• liver disease
• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• a breathing problem or chronic cough that lasts or 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 use more than directed
Stop use and ask a doctor if
• nervousness, dizziness or sleeplessness occur
• redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• fever gets worse or lasts more than 3 days
• new symptoms occur
• cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a
serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
OVERDOSAGE SECTION
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or
contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
• take only as recommended (see Overdose warning)
• use dosage cup
• mL =milliliter
• do not take more than 6 doses in any 24-hour period
| Adults & children 12 years and older | 20 mL every 4 hours |
| Children under 12 years of age | Do not use |
OTHER SAFETY INFORMATION
Other information
• each 20 mL contains: sodium 10 mg
• dosage cup provided
• store between IS-30°C (59-86°F)
• do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate,
purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Maximum Strength MAX COLD & SINUS
AP SAFE NDC 76281-515-25
Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*
Maximum Strength
MAX COLD & SINUS
Acetaminophen /
Pain reliever/Fever Reducer
Guaifenesin /Expectorant
Phenylephrine HCl / Nasal decongestant
Cold & Sinus
Relief of:
• Fever & Bodyaches
• Thins & Loosens Mucus
• Nasal & Chest Congestion
Adults- For Ages 12 and over
6 FL OZ ( 177 mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in serious consequences.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold &
Sinus.
res
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116568 | acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 1 |
| 1116568 | acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1116568 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 1 |
| 1116568 | acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 1 |
| 1116568 | APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 1 |
| 1116568 | APAP 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-515-25 | Maximum strength Max Cold and Sinus | 177 mL in 1 BOTTLE | LIQUID | 177 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Maximum strength Max Cold and Sinus
- ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCl
- ACETAMINOPHEN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- PROPYL GALLATE
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-515 | 76281-515-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Maximum strength Max Cold and Sinus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | AptaPharma Inc. | 263dae13-5f92-4505-8bcc-e903d05b9a0c | 2024-01-31 | Warnings | 76281-515-25 76281-515 76281051525 ca73e55a-9cf6-4629-9e2d-2c2c9f328ad2 263dae13-5f92-4505-8bcc-e903d05b9a0c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.