Label: COLTALIN-ND- acetaminophen, phenylephrine hydrochloride tablet
- NDC Code(s): 51467-008-01, 51467-008-02
- Packager: FORTUNE PHARMACAL COMPANY LIMITED
- 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 February 22, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
■ adult takes more than 12 tablets in 24 hours, which the maximum daily amount for this product
■ child takes more than 5 doses in 24 hours
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks everyday while using this product -
DO NOT USE
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.
for fever for more than 3 days, unless directed by a physician
■ 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 whether a prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
■ sore throat is severe
■ sore throat persists for more than 2 days
■ sore throat is accompanied or followed by:
■ fever
■ headache
■ rash
■ nausea
■ vomiting
■ nervousness, dizziness, or sleeplessness occur
■ fever gets worse or lasts more than 3 days
■ any of the following occurs (these could be signs of a serious condition):
■ new symptoms occur
■ pain or fever persist or gets worse
■ redness or swelling is presentDo not give to children under 6 years of age unless directed by a doctor.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor
■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor
■ children under 6 of age : consult a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
COLTALIN-ND
Non-Drowsy
Safely Sealed
NDC 51467-008-01
Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal DecongestantCold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage24 Tablets
In Individually Sealed Strip
Aspirin Free
-
PRINCIPAL DISPLAY PANEL
COLTALIN-ND
Non-Drowsy
Safely Sealed
NDC 51467-008-02
Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal DecongestantCold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage36 Tablets
In Individually Sealed Strip
Aspirin Free
-
INGREDIENTS AND APPEARANCE
COLTALIN-ND
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51467-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FD&C RED NO. 40 (UNII: WZB9127XOA) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color pink Score no score Shape ROUND Size 12mm Flavor Imprint Code FORTUNE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51467-008-01 2 in 1 BOX 03/01/2004 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51467-008-02 3 in 1 BOX 04/26/2016 2 12 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 03/01/2004 Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561) Establishment Name Address ID/FEI Business Operations FORTUNE PHARMACAL COMPANY LIMITED 686280561 manufacture(51467-008)