ALLERGY AND COLD
diphenhydramine hydrochloride and
phenylephrine hydrochloride capsule, gelatin coated WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
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.
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies:
itchy, watery eyes
minor aches and pains
itching of the nose or throat
temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take:
more than 12 gelcaps 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
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.
with any other product containing diphenhydramine, even one used on skin.
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.
Ask a doctor before use if you have
high blood pressure
trouble urinating due to an enlarged prostate gland
cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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
taking sedatives or tranquilizers
When using this product
do not exceed recommended dosage
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not use more than directed (see overdose warning)
adults and children 12 years and over
take 2 gelcaps every 4 hours
do not take more than 12 gelcaps in 24 hours
children under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
store between 20º to 25ºC (68º to 77ºF). Avoid high humidity.
see end flap for expiration date and lot number
colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C red #28, D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, proplyene glycol, shellac glaze, stearic acid, titanium dioxide
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*Compare to the active ingredients in Benadryl® Allergy Plus Cold