FLU AND SORE THROAT- acetaminophen, diphenhydramine hcl, phenylephrine hcl liquid
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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 30 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Nasal decongestant
Uses
- for the temporarily relief of the following cold/flu symptoms
- minor aches and pains
- headache
- runny nose
- sneezing
- itching of the nose or throat
- sore throat
- nasal and sinus congestion
- itchy, watery eyes
- 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
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
- 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 product containing diphenhydramine, even one used on skin
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- glaucoma
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
-
do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- 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
- nervousness, dizziness, or sleeplessness occurs
- pain, or nasal congestion gets worse, or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- mL = milliliter
- keep dosing cup with product
- adults and children 12 years and over:
- children under 12 years of age: do not use
Other information
- each 30 mL contains: potassium 10 mg
- each 30 mL contains: sodium 14mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, citric acid, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate
Principal Display Panel
Adult
FLU & SORE THROAT Relief
Pain Reliever/Fever Reducer - Acetaminophen
Antihistamine - Diphenhydramine HCl
Nasal Decongestant - Phenylephrine HCl
RELIEVES
- Aches, Fever & Sore Throat
- Runny Nose & Sneezing
- Itchy, watery Eyes
- Itchy Nose or Throat
- Nasal Congestion
Alcohol 10 %
For Ages 12 Years & Over
Cherry Flavor
Distributed by: SELECT BRAND® DISTRIBUTORS
Pine Bluff, AR 71603 USA AC (870) 535-3635
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
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