Label: SAFETUSSIN HIGH BLOOD PRESSURE AND DIABETES COUGH, COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and guaifenesin liquid
- NDC Code(s): 55505-217-36
- Packager: KRAMER LABORATORIES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2023
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- ACTIVE INGREDIENT
- Uses
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Warnings
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
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- taken with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:- ▪
- Skin reddening
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- Blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- If you have ever had an allergic reaction to this product r any of its ingredients
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- In children under 12 years of age
Ask a doctor before use if you have
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- liver disease
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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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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INGREDIENTS AND APPEARANCE
SAFETUSSIN HIGH BLOOD PRESSURE AND DIABETES COUGH, COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-217 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55505-217-36 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/17/2023 Labeler - KRAMER LABORATORIES (122720675)
