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Daytime Cold and Flu Maximum Strength — Shield Pharmaceuticals Corp
This page contains 16 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, oral route. Label set 67849e09-2056-4013-98b1-d003ed3250a2, 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 these symptoms due to a cold or flu: minor aches and pains headache cough nasal congestion sore throat sinus congestion and pressure temporarily reduces fever
Directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 Softgels with water every 4 hrs. Do not exceed6 softgels in 12 hours or as directed by a doctor children under 12 yrs do not use
Table text from source:
| adults & children 12 yrs & over | 2 Softgels with water every 4 hrs. Do not exceed6 softgels in 12 hours or as directed by a doctor
| children under 12 yrs | do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock. If a skin or general allergic 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 is 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 10 mg Phenylephrine HCl 5 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 if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have liver diseaseheart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostat gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
While using this medicine
When using this product • do not use more than directed.
When to stop use and seek help
Stop use and ask a doctor if pain, cough, or nasal congestion 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 nervousness, dizziness, or sleeplessness occurs
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.