SAFETUSSIN HIGH BLOOD PRESSURE AND DIABETES COUGH, COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and guaifenesin liquid 
KRAMER LABORATORIES

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SAFETUSSIN High Blood Pressure Nighttime COLD & FLU

Drug Facts

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

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
taken with other drugs containing acetaminophen
3 or more alcoholic drinks every day 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.

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

 
Do not use more than as directed

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.

If pregnant or breast-feeding, ask a health professional before use.

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.

Distributed by

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

Safetussin High Blood Pressure Multi symtoms relief 8 FL OZ (237 ml)
SAFETUSSIN HIGH BLOOD PRESSURE AND DIABETES  COUGH, COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-217
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-217-36237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/17/2023
Labeler - KRAMER LABORATORIES (122720675)

Revised: 12/2023
Document Id: 7d52a2aa-1c9f-4d02-ae7e-77dde20c3450
Set id: 279e309c-040d-4001-808d-b7d986a9a1d8
Version: 2
Effective Time: 20231218
 
KRAMER LABORATORIES