Head Congestion and Mucus
- Dosage form
- TABLET, FILM COATED
- Labeler
- Cardinal Health 110, LLC. DBA Leader
- Label updated
- 2026-07-08
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · GUAIFENESIN · PHENYLEPHRINE HYDROCHLORIDE
Active ingredients (in each caplet)
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer
Expectorant
Nasal decongestant
Uses
- temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
- headache
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- heart disease
- diabetes
- thyroid disease
- liver disease
- difficulty in urination due to enlargement of the prostate gland
- 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.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- 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
Other information
- each caplet contains: sodium 3 mg
- see end flap for expiration date and lot number
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-800-426-9391
Principal display panel
LEADER™
NDC 70000-0083-1
Non-Drowsy
Head Congestion
& Mucus
Acetaminophen
| Guaifenesin | Phenylephrine HCl
Pain Reliever / Fever Reducer | Expectorant | Nasal Decongestant
Relieves:
Sinus Pressure
Headache
Chest Congestion
COMPARE TO
SUDAFED PE® HEAD
CONGESTION + MUCUS
active ingredients*
100% Money Back Guarantee
24 Caplets
Actual Size
[Image in the official label — see DailyMed source]
DailyMed Set ID: 7418d92d-a540-40d6-91d0-b7eb1f87f8ff · Version 10
NDC: 70000-0083