Indications and uses
temporarily relieves these common cold and flu symptoms: nasal congestion cough headache minor aches and pains sinus congestion and pressure temporarily reduces fever temporarily promotes nasal and/or sinus drainage
Maximum Strength Congestion and Headache
- Manufacturer
- Walgreens | Spirit Pharmaceuticals LLC | MEDGEL PVT LTD
- Effective date
- 2020-04-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:36:32
Label at a glance#
ProductMaximum Strength Congestion and Headache
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use
Storage and handling
store at 20-25°C (68-77°F) avoid excessive heat
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each liquid gel) | Purposes |
|---|---|
| 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 and flu symptoms:
- nasal congestion
- cough
- headache
- minor aches and pains
- sinus congestion and pressure
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 12 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- 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)
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not use more than directed
OTC - STOP USE SECTION
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.
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.
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.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 12 softgels in any 24-hour period
- adults and children 12 years of age and older: take 2 softgels every 4 hours
- children under 12 years of age: do not use
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat
Inactive ingredients
FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil, polyethylene glycol, povidone, propylene glycol, shellac, sorbitol sorbitan solution, titanium dioxide, water
Questions?
1-888-333-9792
PRINCIPLA DISPLAY PANEL
MAXIMUM STRENGTH
CONGESTION &
HEADACHE
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant
Relieves Headache & Fever
Controls Cough
Relieves Nasal Congestion
16
SOFTGELS
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-5556-16 | 2022-02-21 | C162847 | 48780-1 | d6a99b39-bcc1-a426-e053-dadaa90af4c2 | Maximum Strength Congestion & Headache |
| 0363-5556-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-bcc1-a426-e053-dadaa90af4c2 | Maximum Strength Congestion & Headache |
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Congestion and Headache
- Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- PROPYLENE GLYCOL
- SORBITOL
- TITANIUM DIOXIDE
- WATER
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-5556 | 0363-5556-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WATER | 059QF0KO0R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| d88b6868-fe02-4653-e053-2a95a90a329c | 11c28c6c-d2f0-4092-8ef1-4262b17be50e | 2022-02-21 | Warnings | 11c28c6c-d2f0-4092-8ef1-4262b17be50e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.