MULTI SYMPTOM SEVERE COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
RARITAN PHARMACEUTICALS INC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredients (in each packet)
Acetaminophen 500 mg
Dextromethorphan hydrobromide 20 mg
Phenylephrine hydrochloride 10 mg
Purposes
Pain reliever/Fever reducer
Cough Suppressant
Nasal Decongestant
Uses
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- temporarily relieves these symptoms due to a cold:
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- minor aches and pains
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- 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:
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- 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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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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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 a 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product
do not exceed recommended dosage
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occurs
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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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- symptoms do not get better or worsen
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- pain, cough or nasal congestion gets worse or lasts more than 7 days
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- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away at 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
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do not use more than directed
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- take every 4 hours, while symptoms persist. do not take more than 6 packets in 24 hours unless directed by a doctor
Age
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Dose
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Adults and children 12 years of age and over
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One packet
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Children under 12 years of age
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Do not use
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- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
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- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.
Other information
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each packet contains: potassium 6 mg
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- store at room temperature. Protect from excessive heat and moisture.
Inactive ingredients
citric acid, caramel, flavors, maltodextrin ,potassium chloride, silica, sucralose, sucrose,
Questions or Comments
1-866-467-2748
Principal Display
DRx Choice®
NDC# 68163-547-06
Compare to the active ingredients in Theraflu® Multi-Symptom Severe Cold*
MULTI-SYMPTOM
Severe Cold
ACETAMINOPHEN -
Pain Reliever/ Fever Reducer
DEXTROMETHORPHAN HBr -
Cough Suppressant
PHENYLEPHRINE HCl -
Nasal Decongestant
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- Aspartame Free
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- Dye free
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- Sodium free
Relieves
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- Body ache
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- Cough
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- Fever
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- Headache
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- Nasal congestion
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- Sore throat pain
Green Tea & Honey Lemon Flavors
Infused with Menthol & Green Tea Flavors
6 PACKETS
TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.
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Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Multi-Symptom Severe Cold.