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Nighttime Cold and Flu Multi Symptom Relief — Shield Pharmaceuticals Corp
This page contains 16 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, oral route. Label set decafa3a-3734-4161-bab0-121945881846, version 2.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Directions • take only as directed • do not exceed 8 softgels per 24 hrs • adults & children 12 yrs & over: 2 Softgels with water every 6 hrs • children 4 to under 12 yrs: ask a doctor • children under 4 yrs: do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4000 mg in 24 hrs, which is the maximum daily amount for this product • 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 • 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.
Unclassified section
Drug Facts
Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779
Active ingredient
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
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
Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin
While using this medicine
When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness
When to stop use and seek help
Stop use and ask a doctor if • pain 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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Other safety information
Other information • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.