Label: COLD SEVERE CONGESTION- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66715-9818-7 - Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 9, 2022
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- Drug Facts
- Active ingredients
- Purpose
- Uses
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Warnings
Liver warning
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
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.
Sore throat warning
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.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.Do not use
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
Ask a doctor before use if you have
■ liver disease■ heart disease
■ diabetes■ thyroid disease
■ high blood pressure
■ trouble urinating due to an enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysemaAsk a doctor or pharmacist before use if you are
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarinStop use and ask a doctor if
Stop use and ask a doctor if
■ 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 is accompanied by a fever, rash or persistent headache
■ nervousness, dizziness, or sleeplessness occur.
These could be signs of a serious condition. - Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
COLD SEVERE CONGESTION
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9818 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color white (white to off-white) Score no score Shape ROUND Size 12mm Flavor Imprint Code FR;12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9818-7 50 in 1 BOX, UNIT-DOSE 09/12/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/12/2014 Labeler - Lil' Drug Store Products, Inc. (093103646)