BENADRYL ALLERGY PLUS COLD
-
acetaminophen,
diphenhydramine hydrochloride and
phenylephrine hydrochloride tablet, film coated
McNeil Consumer Healthcare Division of McNeil-PPC, 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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Uses
- temporarily relieves these symptoms of the common cold or hay fever or other upper respiratory allergies:
- runny nose
- nasal congestion
- headache
- sore throat
- cough
- sneezing
- minor aches and pains
- itchy, watery eyes
- itching of the nose or throat
- sinus congestion and pressure
- temporarily reduces fever
Warnings
Liver warning
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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
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 dose
- 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.
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. (1-800-222-1222) 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 use more than directed (see overdose warning)
| adults and children 12 years and over |
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| 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 |
Other information
- store between 20-25°C (68-77°F). Avoid high humidity.
- tamper evident statement
- see side panel for lot number and expiration date
Inactive ingredients
benzyl alcohol, butylparaben, carboxymethylcellulose sodium, corn starch, D&C red #28, D&C yellow #10, D&C yellow #10 aluminum lake, edetate calcium disodium, FD&C red #40, FD&C yellow #6, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylparaben, red iron oxide, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide
| BENADRYL ALLERGY PLUS COLD
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coated |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC MONOGRAPH FINAL | part341 | 07/01/2008 | 12/31/2011 |
| Labeler - McNeil Consumer Healthcare Division of McNeil-PPC, Inc. (878046358) |
Revised: 09/2012 McNeil Consumer Healthcare Division of McNeil-PPC, Inc.