Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI
Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Nighttime Cold and Flu Maximum Strength. Available dosage form: liquid.
Drug Details
- Generic Name
- Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI
- Brand Names
- Nighttime Cold and Flu Maximum Strength
- Application Number
- M012
- Sponsor
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- NDC Codes
- 2
- Dosage Forms
- LIQUID
- Routes
- ORAL
- Active Ingredients
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Indications and Usage
Uses Nighttime temporarily relieves these common cold and flu symptoms minor aches and pains headache sore throat sneezing runny nose nasal congestion cough controls cough to help your child get to sleep temporarily reduces fever Daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive temporarialy relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help your child get to sleep nasal congestion due to a cold stuffy nose
Warnings
Warnings NIGHTTIME Liver warning : This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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 : 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 Nighttime with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product with any other drug containing diphenhydramine, even one used on skin. If your child is allergic to acetaminophen or any of the inactive ingredients in this product to make a child sleepy Daytime in a child who is taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression,psychiatic 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 giving this product. Ask a doctor before use if you have Nighttime liver disease heart disease thyroid disease diabetes glaucoma high blood pressure a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus) Daytime heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if you are Nighttime taking the blood thinning drug warfain taking sedative or tranquilizers When using these products Nighttime do not use more than directed marked drowsiness may occur excitablity may occur, especially in children sedatives and tranquilizer may increase drowsiness Daytime do not use more than directed Stop use and ask a doctor if Nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or last more than 5 days redness or swelling is present new symptoms occurs fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions. Daytime nervousness, dizziness or sleeplessness occur symptoms do not better within 7 days or occur with fever cough lasts more than 7 days, comes back or occur with a fever, rash, or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. Nighttime 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 even if you do not notice any sign or symptoms. Daytime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.