Severe Cold and Cough Relief by AAFES/Your Military Exchanges Drug Facts
Severe Cold and Cough Relief by
Drug Labeling and Warnings
Severe Cold and Cough Relief by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SEVERE COLD AND COUGH RELIEF NIGHTTIME- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
AAFES/Your Military Exchanges
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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Drug Facts
Active ingredients (in each 30 mL)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Uses
- temporarily relieves these symptoms due to a cold
- minor aches and pains
- headache
- sore throat
- runny nose
- itchy, watery eyes
- sneezing
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- itching of the nose or 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
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 drugs 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
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- 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
- sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- alcohol, sedatives, and tranquilizers may increase drowsines
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- marked drowsiness may occur
- excitability may occur, especially in children
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- pain, cough 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
- cough comes back or occurs with a fever, rash or headache that lasts
These could be signs of a serious condition.
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
- 30 mL every 4 hours
- children under 12 years of age: do not use
Other information
- each 30 mL contains: potassium 10 mg
- each 30 mL contains: sodium 14 mg
- store at 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
Severe Cold and Cough Relief
Nighttime
Acetaminophen 650 mg
Pain reliever/fever reducer
Diphenhdyramine HCl 25 mg/antihistamine/cough suppressant
Phenylephrine HCl 10 mg/nasal decongestant
cough
runny nose and sneezing
itchy nose or throat
itchy, watery eyes
aches, fever and sore throat
nasal congestion
Adults 12 years and over
Cherry flavor
alcohol 10%
Questions or comments?
Call 1-877-753-3935
Monday-Friday 9AM-5PM EST
FL OZ (mL)
Questions or comments: 1-855-331-FRED (3733)
Compare to the Active Ingredients in Theraflu® Nighttime Severe Cold & Cough*
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Novartis Consumer Health Inc., distributor of Theraflu® Nighttime Severe Cold & Cough.
Manufactured for Yor Military Exchabges
By; PL Developments, 11865 S. Alameda St
Lynwood, CA 90262
| SEVERE COLD AND COUGH RELIEF
NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid |
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| Labeler - AAFES/Your Military Exchanges (001695568) |