- Human OTC
- Expectorant
Drug Classes
Expectorant
alpha-1 Adrenergic Agonist
Cold Remedies,other
Prostaglandin Receptor Antagonists
Adrenergic alpha-Agonists
Adrenergic alpha1-Agonists
- Chain Drug Marketing Association
Version History
Go PRO to access past versions
- SPL 3 - Dec 19, 2022
- SPL 2 - Oct 08, 2019
- SPL 1 - Jun 16, 2015
Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride is used for the treatment ofFever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Cough Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
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IMPRINT: AAA 1166 SHAPE: oval
COLOR: orange
All Imprints
acetaminophen 325 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet - aaa 1166 oval orange
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Drug Facts
Otc - Active Ingredient Section
OTC - PURPOSE SECTION
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant
Uses
- temporarily relieves:
- nasal congestion
- headache
- minor aches and pains
- sinus congestion and pressure
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets 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
- bulers
- 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.
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, chronic bronchitis, 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
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 persistent headache
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 (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)
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older:Â take 2 caplets every 4 hours
- children under 12 years of age:Â do not use
Other Information
- store between 20-25°C (68-77°F) in a dry place
- retain outer package for complete product information
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Principal Display Panel
Quality Choice®NDC 63868-722-20
âCompare to Active Ingredients in Mucinex® Sinus-Max⢠Severe Congestion Relief
Maximum Strength*
Mucus Relief Sinus
Severe Congestion Relief
Pain Reliever, Expectorant, Nasal Decongestant
Acetaminophen, Guaifenesin, Phenylephrine HCl
For Relief of:
Sinus Congestion
Headache
Thins & Loosens Mucus
For Ages 12+
20 Caplets
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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