FDA Label for Dg Health Tussin
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Dg Health Tussin Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 20 Ml)
Acetaminophen, USP 650 mg
Diphenhydramine HCl, USP 25 mg
Phenylephrine HCl, USP 10 mg
Purposes
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Uses
• temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other respiratory allergies:• cough due to minor throat and bronchial irritation• nasal congestion• headache• sore throat• minor aches and pains• runny nose• sneezing• itchy, watery eyes• itching of the nose and throat• temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this product• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
• to sedate a child or to make a child sleepy• 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.• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.• with any other product containing diphenhydramine, even one used on skin• if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• glaucoma• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• a breathing problem such as emphysema or chronic bronchitis• persistent or chronic cough such as occurs with smoking, asthma or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
• taking the blood thinning drug warfarin• taking sedatives or tranquilizers
When Using This Product
• do not use more than directed• marked drowsiness may occur• avoid alcoholic drinks• alcohol, sedatives, and tranquilizers may increase drowsiness• be careful when driving a motor vehicle or operating machinery• excitability may occur, especially in children
Stop Use And Ask A Doctor If
• you get nervous, dizzy or sleepless• 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• do not take more than 5 doses in any 24-hour period• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.• measure only with dosing cup provided• keep dosing cup with product• mL = milliliter• this adult product is not intended for use in children under 12 years of age
age | dose |
adults and children 12 years and over | 20 mL every 4 hours |
children under 12 years | do not use |
Other Information
• each 20 mL contains: sodium 11 mg• store at 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin
Questions Or Comments?
1-888-309-9030
Package/Label Principal Display Panel
Compare to the active ingredients of Robitussin® Severe Multi-Symptom Cough Cold + Flu Nighttime
For Ages 12 & Over
Adult
Max Strength
CF Night Time MAX
Tussin
Pain Reliever/Fever Reducer
(Acetaminophen)
Antihistamine/Cough Suppressant
(Diphenhydramine HCl)
Nasal Decongestant
(Phenylephrine HCl)
Severe
Multi-Symptom
Cough Cold + Flu
Night Time
Relieves:
Cough
Sore Throat
Body Aches
Fever
Nasal Congestion
Runny Nose
4 FL OZ (118 mL)
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