• 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
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
Drug Facts
Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Expectorant
Nasal decongestant
• 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
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.
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, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin
When using this productdo not exceed recommended dose
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. (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.
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 |
• store between 20-25° C (68-77° F)
1-800-373-6981 (toll-free)
croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol , polyvinyl alcohol, povidone, purified water, starch, talc, titanium dioxide
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0121-6 | Severe Sinus Congestion and Pain | 60 in 1 BOTTLE | TABLET, COATED | 60 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 83059-0121 | 83059-0121-6 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | d0dd4a75-da65-4c66-b65f-54ee14100846 | 2025-12-05 | Warnings | 83059-0121-6 83059-0121 83059012106 453c4412-3578-f829-e063-6394a90a9024 d0dd4a75-da65-4c66-b65f-54ee14100846 |
Adverse event summaries are temporarily unavailable. Other product information remains available.