Label: ALLERGY AND COLD- acetaminophen, diphenhydramine hcl and phenylephrine hcl capsule, gelatin coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 59779-583-08 - Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 11, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
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.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- 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.
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.
-
Directions
- 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
- Other information
-
Inactive ingredients
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
- Questions or comments?
-
Principal Display Panel
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
CVS®
pharmacy
*Compare to the active ingredients in Benadryl® Allergy Plus Cold
NEW!
ALLERGY & COLD
WITH FEVER REDUCER
ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
Pain reliever/Fever reducer, Antihistamine/Cough suppressant,
Nasal decongestant
See New Warnings Information
Relief of:
✓ Headache
✓ Sneezing
✓ Sore throat & Fever
✓ Itchy, watery eyes
✓ Sinus congestion
✓ Runny nose
✓ Itchy Throat
✓ Cough
24 GELCAPS
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING
Distributed by:
CVS Pharmacy, Inc.
One CVS Dive
Woonsocket, RI 02895
© 2010 CVS/pharmacy
www.cvs.com
1-800-shop-CVS
50844 ORG110958308
-
INGREDIENTS AND APPEARANCE
ALLERGY AND COLD
acetaminophen, diphenhydramine hcl and phenylephrine hcl capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-583 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) D&C RED NO. 28 (UNII: 767IP0Y5NH) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (pink with grey band) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code L;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-583-08 1 in 1 CARTON 1 24 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/10/2009 Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)