FDA Label for Sanatos Severe Cold And Cough Nighttime
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- 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 DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Sanatos Severe Cold And Cough Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel 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.
Other
Drug Facts
Distributed by:
PHARMADEL
Georgetown, DE 19947
Made in India
Otc - Purpose
Active Ingredients (in each packet) | Purposes |
---|---|
Acetaminophen 650 mg | Pain reliever/ fever reducer |
Diphenhydramine HCI 25 mg | Antihistamine/ cough suppressant |
Phenylephrine HCI 10 mg | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- headache
- sore throat
- minor aches & pains
- nasal congestion & itchy, watery eyes due to hay fever
- other respiratory allergies
- cough due to minor throat & bronchial irritation
- itchy nose and throat
- runny nose
- sneezing
- stuffy nose
- and reduces fever
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
- 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
- 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.
- for more than 7 days for pain and 3 days for fever, unless directed by a doctor
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema
- chronic bronchitis
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- may cause excitability especially in children
- may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages while taking this product
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask Doctor If
- new symptoms occur
- pain or fever persists or gets worse
- symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- if nervousness, dizziness, or sleeplessness occur
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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. 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 exceed recommended dosage
- take every 4 hours; do not take more than 6 packets in 24- hour period
- dissolve contents of one packet into 8 oz. hot water and sip while hot; consume entire drink within 10-15 minutes
- if using a microwave; add contents of one packet to 8 oz. of cool water, stir briskly before and after heating. Do not overheat.
Dosage & Administration
Age | Dose |
adults & children 12 years of age & over | one packet every 4 hours |
children under 12 years of age | do not use |
Other Information
- each packet contains: potassium 10 mg, sodium 27 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at room temperature 68-77°F (20-25°C)
- protect from excessive heat and moisture
TAMPER EVIDENT: Do not use if packets are broken or torn.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow 10, FD&C blue 1, FD&C red 40, flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water
Questions Or Comments?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Principal Display Panel
SanaTos ®Severe COLD & COUGH Nighttime
NDC 55758-009-01
NDC 55758-009-06
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