Other
Drug Facts
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
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Safetussin High Blood Pressure And Diabetes Liquid
FDA Label NDC 55505-217
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Safetussin High Blood Pressure And Diabetes (NDC 55505-217). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 30 mL dose cup) | Purpose |
|---|---|
Acetaminophen 650 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 20 mg | Cough suppressant |
Guaifenesin 400 mg | Expectorant |
Uses
temporarily relieves common cold/flu symptoms:
▪ cough▪ sore throat▪ headache▪ minor aches and pains▪ fever▪ helps loosen phlegm (mucus) and thin bronchial secretions to get 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 6 doses in 24 hours, which is the maximum daily amount for this product▪ taken with other drugs containing acetaminophen▪ 3 or more alcoholic drinks every day while using this product
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
▪ 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 r any of its ingredients▪ In children under 12 years of age
Ask A Doctor Before Use If You Have
▪ liver disease▪ 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
Stop Use And Ask A Doctor If
▪ nervousness, dizziness, or sleeplessness occur▪ 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
▪ do not take more than directed▪ do not take more than 6 doses in any 24-hours period▪ measure only with dosing cup provided▪ dose as follows or as directed by a doctor
adults & children 12 years & older | 30 mL per dose every 4 hours |
children under 12 years of age | do not use |
Other Information
- each 30 mL contains: sodium19 mg
- store at room temperature. Do not refrigerate.
Inactive Ingredients
Anhydrous citric acid, edetate disodium, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum.
Principal Display Panel - 236 Ml Bottle Label
SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES
NDC 55505-217-36
Safetussin®
MAX STRENGTH
MULTI-SYMPTOM
Cough, Cold & Flu
Acetaminophen / Pain Reliever 650 mg
Dextromethorphan HBr / Cough Suppressant 20 mg
Guaifenesin / Expectorant 400 mg
Safe for adults with
High Blood Pressure
Diabetes
Relieves
✓ Headache✓ Fever✓ Sore Throat✓ Body Aches & Pains✓ Chest Congestion✓ Cough
Safetussin® contains:
No decongestants
No Sugar
No Alcohol
No sorbitol
No fructose
No gluten
No dyes
Pharmacist Recommended Brand
Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.
8 FL OZ (237 mL)
Questions? Comments? Call 1-800-824-4894
©2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807
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