Indications and uses
temporarily relieves these common cold/flu symptoms: sinus congestion and pressure nasal congestion cough sore throat minor aches and pains headache promotes nasal and sinus drainage temporarily reduces fever
cough and sinus PE
- Manufacturer
- Meijer
- Effective date
- 2022-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:46:06
Label at a glance#
Productcough and sinus PE
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Storage and handling
store between 20-25°C (68-77°F) in a dry place retain carton for complete product information
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 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:
- sinus congestion and pressure
- nasal congestion
- cough
- sore throat
- minor aches and pains
- headache
- promotes nasal and sinus drainage
- temporarily reduces fever
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)
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
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
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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions or comments?
1-844-705-4384
PRINCIPAL DISPLAY PANEL
NDC 41250-372-02
Compare to Sudafed PE® Pressure + Pain + Cough active ingredients†
Meijer®
NON-DROWSY
cough + sinus PE
Acetaminophen | Phenylephrine HCl | Dextromethorphan HBr
Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant
Relief of: Sinus Headache & Sore Throat;
Sinus Pressure & Congestion; Cough
Pressure,
Pain & Cough
For Adults
24 CAPLETS
actual size
Products#
Every source-derived product name is available through these pages.
- cough and sinus PE
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- CROSPOVIDONE
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL
- POVIDONE, UNSPECIFIED
- STARCH, PREGELATINIZED CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41250-372 | 41250-372-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ee9e15b1-15b2-d00e-e053-2a95a90aa798 | 81cbcbb3-6811-3ce6-e053-2a91aa0a9655 | 2022-11-29 | Warnings | ee9e15b1-15b2-d00e-e053-2a95a90aa798 81cbcbb3-6811-3ce6-e053-2a91aa0a9655 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.