pilldic.Your medicine dictionary
Text size
← US medicines
US · Over-the-counter medicine

Severe Sinus Congestion and Pain

Dosage form
TABLET, COATED
Labeler
Shield Pharmaceuticals Corp
Label updated
2025-12-05
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · GUAIFENESIN
View original label and images on DailyMed ↗
Label information

Drug Facts

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:
• sinus congestion and pressure
• headache
• nasal congestion
• minor aches and pains
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• 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.

Label information

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.

Label information

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, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

Label information

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

Label information

When using this productdo not exceed recommended dose

Label information

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.

Label information

If pregnant or breast-feeding,ask a health professional before use.

Label information

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 • 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

• store between 20-25° C (68-77° F)

Questions or comments?

1-800-373-6981 (toll-free)

Inactive ingredients

croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide

Label information

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

포장 표시

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

DailyMed Set ID: d0dd4a75-da65-4c66-b65f-54ee14100846 · Version 2
NDC: 83059-0121