RxNorm Names
Review RxNorm Normal Forms
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
(acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride)
tablet, coated
[AAA Pharmaceutical, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ab34d57c-f952-4121-96bc-16cb2b47397b| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- impulse to cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
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 every day while using this product
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.
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)
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.
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)
| 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
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #2, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL - 24 Caplet Carton
RESTORE u
NDC 57344-159-02
†COMPARE TO THE ACTIVE
INGREDIENTS IN TYLENOL®
COLD HEAD CONGESTION
SEVERE
DAYTIME
NON-DROWSY
Severe Cold
HEAD CONGESTION
Pain Reliever/Fever Reducer, Nasal Decongestant,
Cough Suppressant, Expectorant
- Headache/Sore Throat – Acetaminophen
- Nasal Congestion – Phenylephrine HCl
- Coughing – Dextromethorphan HBr
- Chest Congestion – Guaifenesin
COOL TASTE
24 CAPLETS
| ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - AAA Pharmaceutical, Inc. (181192162) |
