Label: ACTI PE- chlorpheniramine maleate, phenylephrine hcl tablet
- NDC Code(s): 59726-890-24
- Packager: P & L Development, LLC
- 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.
Updated December 5, 2019
If you are a consumer or patient please visit this version.
- Active ingredients (in each tablet)
Do not use
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
- heart disease
- trouble urinating due to an enlarged prostate gland
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- symptoms do not get better within 7 days or are accompanied by a fever
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to the active ingredients in Actifed® Cold & Allergy**
chlorpheniramine maleate 4mg
phenylephrine HCI 10mg
- nasal congestion
- runny nose
- itchy, watery eyes
Does not contain Pseudoephedrine
**This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Actifed® Cold & Allergy.
TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT.KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
200 Hicks Street
Westbury, NY 11590
- Product Label
INGREDIENTS AND APPEARANCE
chlorpheniramine maleate, phenylephrine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-890 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code T127 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-890-24 24 in 1 CARTON 02/28/2015 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/28/2015 Labeler - P & L Development, LLC (800014821)