Label: ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL capsule, liquid filled
- NDC Code(s): 69729-782-10
- Packager: OPMX LLC
- 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.
Updated February 18, 2019
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
- Take only as directed (See overdose warning)
- Do not exceed 4 doses per 24-hours
- Adults and children 12 years and over: take 2 softgels with water every 4 hours
- Children 4 to under 12 years: ask a doctor
- When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing
INDICATIONS & USAGE
Temporarily relieves common cold/flu symptoms:
- Nasal congestion
- Sinus congestion & pressure
- Cough due to minor throat & bronchial irritation
- Minor aches & pain
- Sore throat
- Reduces swelling of nasal passages
- Temporarily restore freer breathing through the nose
- 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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 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:
High blood pressure
Trouble urinating due to enlarged prostate gland
Cough that occurs with too much phlegm (mucus)
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if:
You get nervous, dizzy, or sleepless
Pain, nasal congestion, or cough gets worse or lasts more than 7 days
Fever gets worse or last 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.
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-782 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) POVIDONE K30 (UNII: U725QWY32X) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) Product Characteristics Color orange (LIGHT ORANGE) Score no score Shape OVAL (Oblong) Size 20mm Flavor Imprint Code 782 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-782-10 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/18/2019 Labeler - OPMX LLC (029918743)